Thermo Fisher Scientific Jobs In Greenville, NC

Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description When you are part the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe! Your work will have a real-world impact, and you'll be supported in achieving your career goals. How will you make an impact? Lead the Steriles North manufacturing team providing technical, mechanical and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. Role and Responsibilities: * Help to ensure successful start-up of new Sterile facility by being a member of the site project team. * Ensure new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines. * Assist with building and training the production team that will staff the new Sterile Filling lines. * Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best. * Supervise employees in day-to-day operations by spending at least 50% of available time collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs). * Ensure that production schedule is met by distributing workload in accordance with changing priorities. * Ensure production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility. * Evaluate/solve operation problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing summary reports/recommendations for management. * Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. * Prepare performance reviews for all employees and evaluate personnel performance according to performance management process. Provide feedback for continuous improvement. Hold staff accountable and apply disciplinary action as required. Assist in hiring staff as needed. Maintain a work environment with cultivate partnership and support the company's continuous improvement process. * Provide training and/or opportunities for career development of staff. Qualifications Education: Bachelor's degree in Science, Engineering, Administration, or other STEM related program is required. Experience: Minimum of four (4) years of technical and/or manufacturing experience. One (1) to five (5) years of supervisory experience preferred. Experience in project management and leading start-up, preferable. Experience with life virus vaccine techniques and procedures Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities: * Knowledge in GMPs and FDA regulations. * Technical writing experience preferred. * Technical and operational knowledge of start-up of aseptic environment for live virus vaccines. * Strong decision-making skills. * Ability to handle multiple ongoing activities and ability to prioritize tasks. * Outstanding attention to detail and organizational skills. * Ability to work in a fast-paced environment under pressure, able to multi-task and is results driven. * Demonstrated ability to maintain a high degree of confidentiality. * Excellent social skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. * Highly effective verbal and technical written communication skills. Able to create SOPs, work instructions and manufacturing process. * Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. * Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. * Lead by example and set the example for others to follow At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing productivity in their laboratories, we are here to support them. Our distributed team of more than 100,000+ colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. Shift hours are 6pm-6am on a 2-2-3 rotating schedule. Location/Division Summary: Greenville, NC/DPD: The Drug Product Division POSITION SUMMARY The Sr. Formulation Technician will be able to perform tasks with little to no direction. They will provide guidance in the absence of the Lead Formulation Technician. They will be proficient in aseptic filling and manufacturing. This colleague follows written and verbal instructions using cGMP documents and operating equipment when performing the following duties. Key Responsibilities: Ensure pharmaceutical products are manufactured in accordance to area SOPs and current cGMP. Verify and document production activities in batch records, logbooks and controlled forms. Complete tasks vital to manufacture drug products in an aseptic filling area, including: Cleaning cGMP Areas Parts Preparation Filter Integrity Testing Operating Parts Washers and Autoclaves Performing Tray Loading Operating the Filling Isolator General Material Handling Troubleshooting Equipment Alarms Designated Trainer/Certified SME Education: High School Diploma or equivalent required. Associate's with 1+ year manufacturing experience preferred. Bachelor's preferred with no manufacturing experience. Experience: Mechanical and/or similar experience preferred. 2 years of Steriles pharmaceutical or manufacturing experience preferred. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities: Excels in a team environment. Basic math skills. Attention to detail while maintaining a quality product. Ability to perform repetitive work duties. Ability to follow SOPs. Ability to concisely communicate with Production leadership to accept daily assignments and report any relevant production-related information. Ability to schedule the team's activities and drive priorities Strong communication skills Proactive in identifying quality opportunities Flexibility/willingness to adapt to operational needs PHYSICAL REQUIREMENTS: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 25-50 pounds, occasionally pushing or pulling more than 100 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. BENEFITS We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (*************************************************************************************** As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

divpb Work Schedule/b/pStandard (Mon-Fri)p/ppb Environmental Conditions/b/pAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. . . allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc. ), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc. ), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heightsp/ppbu Job Description/u/b/pp/ppb Location:/b bGreenville, NC/b/ppb Company information/b/pp As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. /ppb Business information/b/pp The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectables and oral solid dose forms. /ppb Position summary/b/pp Provides direct quality support (e. g. compliance, regulatory assessment, and validation) to the business unit, clients and corporate management through the leading and performing tasks associated with key quality functions. Supervises and/or leads lower level staff as assigned. Builds, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues. Crafts systems to drive compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company. /ppb Key Responsibilities:/b/pulli Manages, leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results. /lili Serves as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinates, reviews and prepares customer audit responses and reports. /lili Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales. /lili Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions. /lili Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems. /lili Coordinates regulatory inspections performed by the FDA, MCA and other regulatory agencies. /lili Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits. /lili Establishes and supervises quality programs and plans (e. g. validation, QAT, supplier certification). /li/ulullib Qualifications:/b/lili Bachelor's degree in Engineering or Biological science related field is preferred. Four (4) years of applicable experience may be considered for equivalency to education. /lili Meaningful work experience in the pharmaceutical or a regulated industry, is preferred. /lili Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. /lili Effective time management and prioritization skills/lili Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills. /li/ulp As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need! #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p/div

Join Us and Make a Difference! At Thermo Fisher Scientific, your work will make a global impact! From protecting the environment to ensuring food safety and supporting life-saving cancer research, we address the world's toughest challenges. About The Role: We need a committed Staff R&D Scientist to lead and assist in developing, optimizing, and validating innovative manufacturing processes. The main focus will be on Oral Solid Dose (OSD) Continuous Manufacturing. You will conduct experiments, analyze data, support product validations, and ensure smooth technology transfers to meet client and regulatory requirements. Your expertise will be essential in achieving our high-reaching goals and making a significant industry impact. Key Responsibilities: Develop, scale up, and optimize manufacturing processes for OSD products, focusing on both continuous and batch manufacturing. Design experiments, analyze data, and apply findings to improve process performance and product quality. Support seamless technology transfers between R&D and commercial production environments. Collaborate with cross-functional teams to ensure efficient process development, validation, and commercialization. Stay updated on industry advancements and incorporate innovative technologies into manufacturing processes. Ensure compliance with regulatory, quality, and safety standards throughout all process activities. Identify and resolve manufacturing challenges while driving continuous improvement and operational efficiency. Education: Bachelor's degree in chemical engineering, chemistry, pharmacy, or a related field with 4+ years of experience, Master's degree with 2+ years, or Ph.D. with no experience required. Experience: At least 4 years of experience in manufacturing, specifically in product or process development. This includes scale-up and technology transfer for immediate and controlled-release dosage forms. In-depth knowledge of GMP, process validation, and regulatory requirements. Strong problem-solving, communication, and project management skills. Proficiency in programming languages such as Python or MATLAB. Solid understanding of statistical tools and their application in process development. Advanced knowledge of continuous manufacturing is preferred. Why Thermo Fisher Scientific? Career Development: Opportunities for learning, growth, and leadership. Benefits: Competitive pay, healthcare, retirement plans, and more. Inclusive Culture: We value different perspectives and cultivate an encouraging environment. Purposeful Work: Join a team that's making a tangible difference in the world! Do you thrive in dynamic environments and love solving sophisticated challenges? If so, we want to hear from you! Reasonable Accommodations We are committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application process, please contact our HR team. Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description When you are part the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe! Your work will have a real-world impact, and you'll be supported in achieving your career goals. How will you make an impact? Lead the Steriles North manufacturing team providing technical, mechanical and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. Role and Responsibilities: Help to ensure successful start-up of new Sterile facility by being a member of the site project team. Ensure new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines. Assist with building and training the production team that will staff the new Sterile Filling lines. Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best. Supervise employees in day-to-day operations by spending at least 50% of available time collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs). Ensure that production schedule is met by distributing workload in accordance with changing priorities. Ensure production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility. Evaluate/solve operation problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing summary reports/recommendations for management. Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. Prepare performance reviews for all employees and evaluate personnel performance according to performance management process. Provide feedback for continuous improvement. Hold staff accountable and apply disciplinary action as required. Assist in hiring staff as needed. Maintain a work environment with cultivate partnership and support the company's continuous improvement process. Provide training and/or opportunities for career development of staff. Qualifications Education: Bachelor's degree in Science, Engineering, Administration, or other STEM related program is required. Experience: Minimum of four (4) years of technical and/or manufacturing experience. One (1) to five (5) years of supervisory experience preferred. Experience in project management and leading start-up, preferable. Experience with life virus vaccine techniques and procedures Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities: Knowledge in GMPs and FDA regulations. Technical writing experience preferred. Technical and operational knowledge of start-up of aseptic environment for live virus vaccines. Strong decision-making skills. Ability to handle multiple ongoing activities and ability to prioritize tasks. Outstanding attention to detail and organizational skills. Ability to work in a fast-paced environment under pressure, able to multi-task and is results driven. Demonstrated ability to maintain a high degree of confidentiality. Excellent social skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and technical written communication skills. Able to create SOPs, work instructions and manufacturing process. Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Lead by example and set the example for others to follow At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Lead client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work. Discover Impactful Work! Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. May be involved in clinical stage of drug development. Crafts technical/scientific process/product/project activities to implement strategies and technical solutions that meet client expectations. Drives the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects from clients. Evaluates and designs manufacturing processes and supports problem solving as needed within defined procedures and practices. Makes decisions that involve direct application of technical knowledge. A Day in the Life. Support manufacturing operations, change controls, investigations as (SME), resolve accurate CAPAs. Design and complete studies, lead tech transfer, commercial scale-up and support process validation. Represent the organization on formal technical and scientific forums. Lead and/or participate in problem solving and project work for formulations, equipment and processes. Write/revise manufacturing and filling work orders for existing and new processes with no supervision. Write reports, protocols, and summaries. Lead projects with minimal to no supervision, can review and plan all technical aspects of the project to meet appropriate timeline and project goals. Assess material changes and change impact. Support creation of proposals and timelines for projects, leading relevant client meetings. Review new bid quotes, protocols, technical documents, results, and reports. Keys to Success Education: Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. Experience: Bachelors and 4+ years of related experience, or, related Master's degree. Experience in a CMO, Technology Transfer, or Pharmaceutical product development PREFERRED Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: Excellent knowledge of pharmaceutical processes, technology transfer, process development, and scientific methodology as related to the pharmaceutical industry. Detailed knowledge of Good Manufacturing Practices. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients. Ability to work on multiple projects simultaneously. Ability to keep current with scientific literature and industry trends. Ability to develop technical solutions. Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights Job Description Location: Greenville, NC Company information As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Business information The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectables and oral solid dose forms. Position summary Provides direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit, clients and corporate management through the leading and performing tasks associated with key quality functions. Supervises and/or leads lower level staff as assigned. Builds, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues. Crafts systems to drive compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company. Key Responsibilities: * Manages, leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results. * Serves as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinates, reviews and prepares customer audit responses and reports. * Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales. * Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions. * Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems. * Coordinates regulatory inspections performed by the FDA, MCA and other regulatory agencies. * Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits. * Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification). * Qualifications: * Bachelor's degree in Engineering or Biological science related field is preferred. Four (4) years of applicable experience may be considered for equivalency to education. * Meaningful work experience in the pharmaceutical or a regulated industry, is preferred. * Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. * Effective time management and prioritization skills * Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need! #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. How will you make an impact? The Sr Formulation Technician will be responsible to produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This colleague follows written and verbal instructions when performing the following duties. Shift hours are 6am-6pm on a 2-2-3 rotating schedule. A Day in the Life: Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP Verify and document production activities in batch records, logbooks and controlled forms Complete tasks vital to manufacture drug products in an aseptic filling area, including: Cleaning cGMP Areas Perform line changeovers Parts Preparation Filter Integrity Testing Operating Parts Washers and Autoclaves Performing Tray Loading and Unloading Operating the Filling Isolator General Material Handling Troubleshooting Equipment Alarms Keys to Success: Education/Experience High School Diploma or equivalent required with 2 years of manufacturing experience. Pharmaceutical, mechanical and/or similar experience preferred. Associate's with 1 year manufacturing experience Bachelor's preferred with no manufacturing experience Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities Excels in a team environment. Basic math skills. Good verbal/written communication. Attention to detail while maintaining a quality product. Ability to perform repetitive work duties. Ability to follow SOPs. Physical & Environmental Requirements Work in a clean-room which is a controlled environment for temperature and humidity having low ambient noise. Wear gowning which includes: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like. Use Personal Protective Equipment (PPE) and understand chemical hygiene. Infrequently lift and manipulate up to 50 pounds max unassisted. Stand and move about including reaching, bending, stooping, grasping. Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. BENEFITS We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description At Thermo Fisher Scientific, your work will make a difference in important areas such as finding cancer cures, environmental protection, and ensuring food safety. You'll have a real-world impact and receive support in achieving your career goals. How will you make an impact? Own the Steriles North manufacturing team providing technical, mechanical, and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. Role and Responsibilities: Help to ensure successful start-up of new Sterile facility by being a member of the site project team. Ensures new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines. Assists with building and training the production team that will staff the new Sterile Filling lines. Leads assigned staff by: supporting organizational change, developing staff, building relationships, positioning staff for success, meeting career and interpersonal goals, forming effective teams, promoting engagement, and fostering motivation. Collaborates with employees to ensure high-quality products that exceed cGMPs, spending at least 50% of available time. Ensures that production schedule is met by distributing workload in accordance with changing priorities. Ensures accurate batch documentation, SOPs, training, critical templates, equipment calibration, and housekeeping in all areas of responsibility for regulatory compliance. Reviews operation problems, develops potential solutions, evaluates or tests solutions, and prepares summary reports/recommendations for management. Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. Holds staff accountable and applies subject area process as required. Assists in hiring staff as needed. Maintains a work environment with nurture partnership and supports the company's continuous improvement process. Provides training and/or opportunities for career development of staff. Education: Bachelor's degree in science, Engineering, Administration, or other STEM related program or equivalent experience is highly preferred. Experience: Minimum four (4) years of technical and/or manufacturing experience. One (1) to five (5) years of supervisory experience preferred. Equivalency: Equivalent combinations of education, training, and equivalent work experience may be considered. Knowledge, Skills, Abilities: Knowledge in GMPs and FDA regulations. Technical writing experience preferred. Technical and operational knowledge of start-up of aseptic environment for live virus vaccines Strong decision-making skills. Skilled in balancing multiple ongoing activities and the ability to prioritize tasks. Outstanding attention to detail Exudes the ability to maintain a high degree of confidentiality. Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle urgent matters. Highly effective verbal and technical written communication skills. Able to develop SOPs, work instructions and manufacturing process. Proven track record to manage and lead professional staff in order to achieve goals, evaluate and resolve sophisticated technical problems. Ability to empower, energize, and retain key staff by direct interactions with supervisors and staff. Leads to set the example for others to follow At Thermo Fisher Scientific, each one of our 100,000 outstanding individuals has an unusual story to tell. Join us and contribute to our outstanding mission-enabling our customers to make the world healthier, cleaner and safer!

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed. Discover Impactful Work! Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. May be involved in clinical stage of drug development. Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client and expectations. Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and designs manufacturing processes and supports problem solving as needed within defined procedures and practices. Makes decisions that involve direct application of technical knowledge. A Day in the Life. Complete studies, tech transfer, commercial scale-up and support process validation. Represent the organization on internal technical discussions. Actively participate in problem solving and project results for formulations, equipment and processes. Write/revise manufacturing and filling work orders for existing and new processes. Write reports, protocols, and summaries. Lead projects with a moderate level of supervision, complete change control actions in a timely manner. Review and plan technical aspects of the project to meet timeline and project goals. Support manufacturing operations, change controls, investigations as SME, Collects data for statistical analysis. Can support interpretation and summary of data. Keys to Success Education: Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. Experience: Bachelors and 2+ years of related experience, or, related Master's degree. Experience in a CMO, Technology Transfer, or Pharmaceutical product development PREFERRED Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: Detailed knowledge of pharmaceutical processes technology transfer and process development. Detailed knowledge of Good Manufacturing Practices. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients. Ability to work on multiple projects simultaneously. Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Ability to keep current with scientific literature and industry trends relating to process technologies. Ability to run technical solutions. Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.

Work Schedule 12 hr shift/days Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: Drug Product Division (DPD), at the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. Day shift hours are 6am-6pm on a 2-2-3 rotating schedule. How Will You Make an Impact? This role will produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This Lead Formulation Technician will work with other Lead Formulation Technicians and colleagues in the department and will be responsible for coordinating the team into accurate work stations daily, ensuring that process execution is efficient and effective, and delivered on schedule, and ensuring that cGMP records are handled according to process and regulatory requirements. A Day in the Life: Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP. Verify and document production activities in batch records, logbooks and controlled forms contemporaneously and accurately. Complete tasks vital to manufacturing drug products in an aseptic filling area, including: Proficient use of production equipment. Cleaning cGMP areas. Filter integrity testing and troubleshooting equipment alarms. Parts preparations. Operating parts washers, autoclaves, and filling isolator. Performing tray loading, unloading and line changeovers. General material handling. Education: High School diploma or equivalent minimally required. Associate or Bachelor's degree preferred. Experience: 3+ years of manufacturing experience. Pharmaceutical or similar experience preferred. Equivalency: Equivalent combinations of education, training and meaningful work experience may be considered. Knowledge, Skills, Abilities: Excels in a collaborative work environment. Basic math skills. Good verbal/written communication. Attention to detail while maintaining a quality product. Ability to perform repetitive work duties and follow SOPs. Ability to work in a fast-paced, priority-changing environment. Ability to drive functional, technical and operational excellence. Ability to inspire and champion innovation, collaboration, visibility, and team effectiveness. Proficient knowledge of SAP Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. Physical Requirements / Work Environment Operate in a clean-room which is a controlled environment for temperature and humidity, having low ambient noise. Wear gowning which includes gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry. Use Personal Protective Equipment (PPE) and understand chemical hygiene. Infrequently lift and manipulate up to 25 pounds max unassisted. Ability to stand and move about including reaching, bending, stooping, grasping, for the majority of a 12-hour shift. Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. What We Offer We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. We offer employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation: Competitive Hourly Pay Rate Additional shift differential for 2nd shift and 3rd shift positions Annual performance-based bonus Annual merit performance-based increase! Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement Employee Referral Bonus! Career Advancement Opportunities Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

The Operations Supervisor is accountable for leading manufacturing employees involved in operations such as manufacturing and filling, This role ensures that high-quality pharmaceutical products are produced according to schedule, cost, and quality standards while maintaining employee engagement, safety performance, and aligning with all regulatory and documentation procedures. Location/Hours: Greenville, NC/M-F 8AM -5PM with occasional overtime to start then will move to 12 hour rotating day shifts 2/2/3 6PM - 6AM. Leadership & Employee Development Lead organizational change, develop and empower staff, and cultivate an inclusive and impactful team. Support team members in achieving both their career goals and interpersonal objectives. Production Oversight & Quality Assurance Lead day-to-day operations, spending at least 50% of the time engaging with employees to ensure compliance with current Good Manufacturing Practices (cGMPs). Lead production schedules and distribute workload based on shifting priorities. Ensure production operations align with regulatory requirements, including accurate batch documentation, and adherence to SOPs. Performance Management & Continuous Improvement Conduct performance evaluations and provide input to employees. Hold employees accountable and apply disciplinary measures when required. Participate in hiring, training, and team development initiatives. Identify and implement process improvements to enhance efficiency and quality. Problem-Solving & Compliance Investigate and resolve operational challenges, developing and testing potential solutions. Maintain compliance with all safety regulations and job-related training requirements to ensure a safe and secure work environment. Other Duties Support company-wide initiatives and perform other assigned duties as needed. Education/Experience: Bachelors Degree preferred, equivalent experience considered 2+ years experience with 1 year previous leadership experience preferred Prior experience within a start up environment preferred Qualifications & Skills: Strong technical and operational knowledge of aseptic processing operations. Ability to multitask in a fast-paced environment while prioritizing critical tasks. Excellent problem-solving skills with a detailed demeanor. Effective written and verbal skills Ability to collaborate cross-functionally to achieve business objectives. Manufacturing Practices (cGMPs). Ensures that production schedule is met by distributing workload in accordance with changing priorities. Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility. Prepares performance reviews for all employees and evaluates personnel performance according to performance management process. Give Input for continuous improvement. Holds staff accountable and applies subject area process as required. Assists in hiring staff as needed. Maintains a work environment that cultivates collaboration and supports the company's continuous improvement process. Evaluates/solves operation problems by reviewing the area of concern, developing potential solutions, technically evaluating or testing the solutions, and preparing summary reports/recommendations for management. Supports the company's safety program to improve safety awareness and provides a safe work environment. Ensures responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Aligns with all job-related safety and other training requirements. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office, manufacturing, and warehouse locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Disclaimer: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employee. Equal Opportunity employer committed to fostering an inclusive and diverse workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other characteristic protected by applicable law.

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed. **Discover Impactful Work!** + Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. + May be involved in clinical stage of drug development. + Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client and expectations. + Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. + Evaluates and designs manufacturing processes and supports problem solving as needed within defined procedures and practices. + Makes decisions that involve direct application of technical knowledge. **A Day in the Life.** + Complete studies, tech transfer, commercial scale-up and support process validation. + Represent the organization on internal technical discussions. + Actively participate in problem solving and project results for formulations, equipment and processes. + Write/revise manufacturing and filling work orders for existing and new processes. + Write reports, protocols, and summaries. + Lead projects with a moderate level of supervision, complete change control actions in a timely manner. + Review and plan technical aspects of the project to meet timeline and project goals. + Support manufacturing operations, change controls, investigations as SME, + Collects data for statistical analysis. Can support interpretation and summary of data. **Keys to Success** **Education:** + Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. **Experience:** + Bachelors and 2+ years of related experience, or, related Master's degree. + Experience in a CMO, Technology Transfer, or Pharmaceutical product development PREFERRED **Equivalency:** + Equivalent combinations of education, training, and meaningful work experience may be considered. **Knowledge, Skills, Abilities:** + Detailed knowledge of pharmaceutical processes technology transfer and process development. + Detailed knowledge of Good Manufacturing Practices. + Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. + Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients. + Ability to work on multiple projects simultaneously. + Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. + Ability to keep current with scientific literature and industry trends relating to process technologies. + Ability to run technical solutions. + Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Flex 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. How Will You Make an Impact?: The Lead Formulation Technician will be responsible to produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This colleague follows written and verbal instructions when performing the following duties. Night shift hours are 6pm-6am on a 2-2-3 rotating schedule. A Day in the Life: Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP. Verify and document production activities in batch records, logbooks and controlled forms. Complete tasks vital to manufacture drug products in an aseptic filling area, including: Cleaning cGMP Areas Filter Integrity Testing and Troubleshooting Equipment Alarms Parts Preparations. Operating Parts Washers, Autoclaves, and Filling Isolator. Performing Tray Loading, Unloading and line changeovers. General Material Handling Education: High School Diploma or equivalent required. Associates or Bachelor's degree preferred. Experience: 3 years of manufacturing experience. Pharmaceutical or similar experience preferred. Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: Excels in a collaborative environment. Basic math skills. Good verbal/written communication. Attention to detail while maintaining a quality product. Ability to perform repetitive work duties and follow SOPs. Physical Requirements / Work Environment Work in a clean-room which is a controlled environment for temperature and humidity having low ambient noise. Wear gowning which includes: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like. Use Personal Protective Equipment (PPE) and understand chemical hygiene. Infrequently lift and manipulate up to 25 pounds max unassisted. Stand and move about including reaching, bending, stooping, grasping. Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds. What We Offer We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation: Competitive Hourly Pay Rate Additional shift differential for 2nd shift and 3rd shift positions Annual performance-based bonus Annual merit performance-based increase! Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement Employee Referral Bonus! Career Advancement Opportunities

The Operations Supervisor is accountable for leading manufacturing employees involved in operations such as manufacturing and filling, This role ensures that high-quality pharmaceutical products are produced according to schedule, cost, and quality standards while maintaining employee engagement, safety performance, and aligning with all regulatory and documentation procedures. Location/Hours: Greenville, NC/M-F 8AM -5PM with occasional overtime to start then will move to 12 hour rotating day shifts 2/2/3 6PM - 6AM. Leadership & Employee Development * Lead organizational change, develop and empower staff, and cultivate an inclusive and impactful team. * Support team members in achieving both their career goals and interpersonal objectives. Production Oversight & Quality Assurance * Lead day-to-day operations, spending at least 50% of the time engaging with employees to ensure compliance with current Good Manufacturing Practices (cGMPs). * Lead production schedules and distribute workload based on shifting priorities. * Ensure production operations align with regulatory requirements, including accurate batch documentation, and adherence to SOPs. Performance Management & Continuous Improvement Conduct performance evaluations and provide input to employees. Hold employees accountable and apply disciplinary measures when required. Participate in hiring, training, and team development initiatives. Identify and implement process improvements to enhance efficiency and quality. Problem-Solving & Compliance Investigate and resolve operational challenges, developing and testing potential solutions. Maintain compliance with all safety regulations and job-related training requirements to ensure a safe and secure work environment. Other Duties Support company-wide initiatives and perform other assigned duties as needed. Education/Experience: * Bachelors Degree preferred, equivalent experience considered * 2+ years experience with 1 year previous leadership experience preferred * Prior experience within a start up environment preferred Qualifications & Skills: * Strong technical and operational knowledge of aseptic processing operations. * Ability to multitask in a fast-paced environment while prioritizing critical tasks. * Excellent problem-solving skills with a detailed demeanor. * Effective written and verbal skills * Ability to collaborate cross-functionally to achieve business objectives. * Manufacturing Practices (cGMPs). * Ensures that production schedule is met by distributing workload in accordance with changing priorities. * Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility. * Prepares performance reviews for all employees and evaluates personnel performance according to performance management process. Give Input for continuous improvement. Holds staff accountable and applies subject area process as required. Assists in hiring staff as needed. Maintains a work environment that cultivates collaboration and supports the company's continuous improvement process. * Evaluates/solves operation problems by reviewing the area of concern, developing potential solutions, technically evaluating or testing the solutions, and preparing summary reports/recommendations for management. * Supports the company's safety program to improve safety awareness and provides a safe work * environment. Ensures responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Aligns with all job-related safety and other training requirements. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office, manufacturing, and warehouse locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Disclaimer: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employee. Equal Opportunity employer committed to fostering an inclusive and diverse workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other characteristic protected by applicable law.

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Lead client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work. **Discover Impactful Work!** + Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. + May be involved in clinical stage of drug development. + Crafts technical/scientific process/product/project activities to implement strategies and technical solutions that meet client expectations. + Drives the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects from clients. + Evaluates and designs manufacturing processes and supports problem solving as needed within defined procedures and practices. + Makes decisions that involve direct application of technical knowledge. **A Day in the Life.** Support manufacturing operations, change controls, investigations as (SME), resolve accurate CAPAs. + Design and complete studies, lead tech transfer, commercial scale-up and support process validation. + Represent the organization on formal technical and scientific forums. + Lead and/or participate in problem solving and project work for formulations, equipment and processes. + Write/revise manufacturing and filling work orders for existing and new processes with no supervision. + Write reports, protocols, and summaries. + Lead projects with minimal to no supervision, can review and plan all technical aspects of the project to meet appropriate timeline and project goals. + Assess material changes and change impact. + Support creation of proposals and timelines for projects, leading relevant client meetings. + Review new bid quotes, protocols, technical documents, results, and reports. **Keys to Success** **Education:** + Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. **Experience:** + Bachelors and 4+ years of related experience, or, related Master's degree. + Experience in a CMO, Technology Transfer, or Pharmaceutical product development PREFERRED **Equivalency:** + Equivalent combinations of education, training, and meaningful work experience may be considered. **Knowledge, Skills, Abilities:** + Excellent knowledge of pharmaceutical processes, technology transfer, process development, and scientific methodology as related to the pharmaceutical industry. + Detailed knowledge of Good Manufacturing Practices. + Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). + Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients. + Ability to work on multiple projects simultaneously. + Ability to keep current with scientific literature and industry trends. + Ability to develop technical solutions. + Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. How will you make an impact? The Formulation Technician II will be responsible to produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This colleague follows written and verbal instructions when performing the following duties. Day shift hours are 6am-2:30pm, Monday - Friday. A Day in the Life: Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP Verify and document production activities in batch records, logbooks and controlled forms Complete tasks vital to manufacture drug products in an aseptic filling area, including: Cleaning cGMP Areas Perform line changeovers Parts Preparation Filter Integrity Testing Operating Parts Washers and Autoclaves Performing Tray Loading and Unloading Operating the Filling Isolator General Material Handling Troubleshooting Equipment Alarms Keys to Success: Education High School Diploma or equivalent minimally required. Associate's with 1 year manufacturing experience. Bachelor's preferred with no manufacturing experience. Experience Required: 2 years of manufacturing experience. Pharmaceutical, mechanical and/or similar experience preferred. Equivalency: Equivalent combinations of education, training and relevant work experience may be considered. Knowledge, Skills, Abilities Excels in a team environment. Basic math skills. Good verbal/written communication. Attention to detail while maintaining a quality product. Ability to perform repetitive work duties. Ability to follow SOPs. Physical & Environmental Requirements Work in a clean-room which is a controlled environment for temperature and humidity having low ambient noise. Wear gowning which includes: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like. Use Personal Protective Equipment (PPE) and understand chemical hygiene. Infrequently lift and manipulate up to 50 pounds max unassisted. Stand and move about including reaching, bending, stooping, grasping. Use hand tools and equipment including forceful gripping, grasping, pushing and pulling.

**Work Schedule** 12 hr shift/nights **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** When you are part the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe! Your work will have a real-world impact, and you'll be supported in achieving your career goals. **How will you make an impact?** Lead the Steriles North manufacturing team providing technical, mechanical and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. **Role and Responsibilities:** + Help to ensure successful start-up of new Sterile facility by being a member of the site project team. + Ensure new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines. + Assist with building and training the production team that will staff the new Sterile Filling lines. + Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best. + Supervise employees in day-to-day operations by spending at least 50% of available time collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs). + Ensure that production schedule is met by distributing workload in accordance with changing priorities. + Ensure production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility. + Evaluate/solve operation problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing summary reports/recommendations for management. + Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. + Prepare performance reviews for all employees and evaluate personnel performance according to performance management process. Provide feedback for continuous improvement. Hold staff accountable and apply disciplinary action as required. Assist in hiring staff as needed. Maintain a work environment with cultivate partnership and support the company's continuous improvement process. + Provide training and/or opportunities for career development of staff. **Qualifications** **Education:** Bachelor's degree in Science, Engineering, Administration, or other STEM related program is required. **Experience:** Minimum of four (4) years of technical and/or manufacturing experience. One (1) to five (5) years of supervisory experience preferred. Experience in project management and leading start-up, preferable. Experience with life virus vaccine techniques and procedures **Equivalency:** Equivalent combinations of education, training, and relevant work experience may be considered. **Knowledge, Skills, Abilities:** + Knowledge in GMPs and FDA regulations. + Technical writing experience preferred. + Technical and operational knowledge of start-up of aseptic environment for live virus vaccines. + Strong decision-making skills. + Ability to handle multiple ongoing activities and ability to prioritize tasks. + Outstanding attention to detail and organizational skills. + Ability to work in a fast-paced environment under pressure, able to multi-task and is results driven. + Demonstrated ability to maintain a high degree of confidentiality. + Excellent social skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. + Highly effective verbal and technical written communication skills. Able to create SOPs, work instructions and manufacturing process. + Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. + Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. + Lead by example and set the example for others to follow At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed. Discover Impactful Work! * Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. * May be involved in clinical stage of drug development. * Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client and expectations. * Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. * Evaluates and designs manufacturing processes and supports problem solving as needed within defined procedures and practices. * Makes decisions that involve direct application of technical knowledge. A Day in the Life. * Complete studies, tech transfer, commercial scale-up and support process validation. * Represent the organization on internal technical discussions. * Actively participate in problem solving and project results for formulations, equipment and processes. * Write/revise manufacturing and filling work orders for existing and new processes. * Write reports, protocols, and summaries. * Lead projects with a moderate level of supervision, complete change control actions in a timely manner. * Review and plan technical aspects of the project to meet timeline and project goals. * Support manufacturing operations, change controls, investigations as SME, * Collects data for statistical analysis. Can support interpretation and summary of data. Keys to Success Education: * Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. Experience: * Bachelors and 2+ years of related experience, or, related Master's degree. * Experience in a CMO, Technology Transfer, or Pharmaceutical product development PREFERRED Equivalency: * Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: * Detailed knowledge of pharmaceutical processes technology transfer and process development. * Detailed knowledge of Good Manufacturing Practices. * Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. * Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients. * Ability to work on multiple projects simultaneously. * Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. * Ability to keep current with scientific literature and industry trends relating to process technologies. * Ability to run technical solutions. * Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.