Analytical Chemist
Chemist Job 43 miles from Pawtucket
Execute routine quality control testing activities as assigned by management. Support CAPA's, change controls, investigations, and deviations. Participate in the development and validation of analytical methods for Analytical Development group. Participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.
Principal Duties and Responsibilities include the following:
Support QC Analytical chemistry testing using laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, Dissolution etc).
Author technical reports as required.
Ensure instrument calibration and qualification is up to date and performed on a scheduled basis.
Troubleshoot any issues with instrumentation and coordinate repair with vendors as necessary.
Coordinate with supervisor on scheduling of testing for reagents and product samples.
Participate in data review.
Participate in method development and validation activities
Coordinate external outsourcing of testing.
Support CAPA, change controls, investigations, and deviations and the timely closure of these items with Quality Assurance.
Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.)
Adherence to cGMPs at all times.
Qualification Requirements:
Bachelor's degree in Chemistry or related field
2+ years' work experience
HPLC / UPLC experience required
Knowledge of CFR 210,211, USP and FDA/ICH guidance an advantage
Experience in a GMP environment required
Knowledge of safe laboratory practices
Strong verbal and written communication skills
Experience with USP App IV dissolution apparatus is preferred
Quality Control Chemist
Chemist Job 44 miles from Pawtucket
Senior Analyst I, Quality Control Chemistry (8 month contract, through 2025)
The Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. Senior Analyst, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed. This position will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to perform routine QC testing of in-process, DS, DP, and raw material samples. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs).
Duties/Responsibilities:
Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)
Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).
Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods.
Method Transfer / Validation of QC chemistry methods at internal and external laboratory.
Model leadership behaviors and mentor/train junior staff
The job responsibilities may change as needed to support activities relevant to the clinical phase.
Qualifications/Requirements:
Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.
Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred.
Experience working with external contract labs (CMOs, CROs) is a plus.
Strong collaboration and team-working skills.
Strong communication, interpersonal and organizational skills.
Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
Chemist
Chemist Job 34 miles from Pawtucket
Worcester, MA
6 month contract
(Target PR: 30-36/hr
· QC background
· Documentation
· Advance testing/CE-SDS, HPLC or ELISA experience
· Empower or Softmax / PLA software experience is a plus
· BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree and 2+ years of related work experience.
We are currently seeking a Chemist II position in Quality Control to join our team. The Chemist II will perform laboratory testing within a fast-paced cGMP environment. Experience with capillary electrophoresis testing is required.
Key Responsibilities Include:
· Performs test methods validations for clinical and commercial projects.
· Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements.
· Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance with procedural requirements.
· Performs a multitude of laboratory techniques for which they are trained.
· Accepts responsibility to complete assigned tasks within required timelines and works with others to accomplish business objectives.
· Authors validation protocols and reports as well as corresponding test methods.
· Support laboratory investigations in a timely manner.
· Support a variety of testing techniques upon completion of training.
Basic:
· BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree
and 2+ years of related work experience.
· CE-SDS, HPLC or ELISA existing experience and troubleshooting experience
· Empower or Softmax / PLA software experience
Preferred:
· Spectrophotometric concentration determination
· Quality Control testing of phase III and commercial products
· Experience with empower audit trail
Quality Control Chemist
Chemist Job 7 miles from Pawtucket
Company Information:
Tedor is a privately held pharmaceutical company a CDMO that develops drug product for both innovator and established companies. We are customer-focused oral solid dose CDMO with a strong track record of meeting aggressive development and commercialization timelines Over the past 20 years we have helped customers received many product approvals.We attribute this success to our company-wide focus on quality, customer service, and meeting timelines. Everything we do, and how we do it, is focused on helping our clients to achieve their product objectives.
Position Summary:
The role of the Quality Control Chemist is a vital role that is essential to manage and execute the quality testing that is required for drug substance on the commercial market.
Quality Control Chemist will also be responsible for method validation and release & stability testing for clinical trial and commercial drug products; therefore, verifying all products and/or substances meet acceptable quality standards and that they are in accordance with the company's policies & procedures, FDA policies & procedures, and any applicable cGMP requirements. Additionally, ensuring compliance, accuracy, and timeliness of specified testing processes, environmental monitoring, data review, data analysis, and data trending of all raw materials, finished formulations, stability samples, client-based & company-based projects, method development, equipment calibrations/qualification and/or transfers, and cleaning study qualifications are all essential responsibilities. Quality Control Chemists are expected to collaborate with QC Analysts and Development Chemists while performing the QC Chemist position.
This is a full-time, non-exempt position that includes a competitive salary, and strong benefits. The Quality Control Chemist will report Directly to the Quality Control Manager or Director.
Position Description:
Responsibilities
Head the collaboration between QC and Developmental Chemists personnel but also cross department collaboration regarding drug product development, commercial operations, commercial manufacturing, Quality Assurance, and Analytical Development.
Evaluation of QC laboratory operational execution and resources needed to preform tests.
Generate, review and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.) as needed.
Revise and manage technical transfer of methods from internal labs for raw material analysis, in-process testing, as well as API and Drug Product testing under supervision of the Director.
Review and report all QC data and generate Certificates of Analysis. Monitor and trend QC data generated by internal and contract testing labs.
Initiate ICH stability study protocols, execute and generate of interim reports.
Manage, write, and review Out of Specification/Atypical results/Out of Trend investigations, deviations, and CAPAs.
Investigate and troubleshoot method issues.
Review relevant sections of regulatory filings.
Monitor calibration schedule.
Contact vendors.
Schedule visits for PM/Calib and repairs.
Assist vendors on site.
Coordinate stability operation activities and ensure quality products and systems.
Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols.
Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications.
Prepare stability data graphs to estimate expiration dates and verify product shelf life.
Evaluate stability trends and prepare reports.
Equipment Qualification, including data integrity program.
Position Type & Expected Hours of Work
This is a full-time, non-exempt position requiring a minimum of 40 hours of work per week, Monday through Thursday and some in person Friday's.. Some responsibilities may require work outside of normal office hours.
Work Environment
Level 2: Office Environment and Laboratory Environment
The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this role and within the daily operations of a professional office environment. Reasonable accommodations may be made to enable employees with disabilities to perform essential functions.
This job operates in a professional office environment, as well as the laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as standard laboratory equipment and instrumentation. An employee in this role will be exposed to standard hazards founds within a laboratory environment such as chemicals; bloodborne pathogens; fumes; select agents; confined spaces. Proper laboratory attire and safety gear such as protective eyewear; laboratory coat; appropriate gloves must be observed.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This role requires standard physical demands within a standard office and laboratory environment where sustained periods of standing, sitting, or walking will be part of an employee's daily routine, whether they are at their desk or in the laboratory. While performing the duties of this role, an employee is regularly required to talk or hear; use hands or fingers to handle or feel; reach with arms; bend or stoop; climb stairs; crawl or crouch; kneel; push or pull; type on a keyboard; use a computer mouse. Lastly, an employee must be able to lift ten (10) pounds.
Travel
Limited travel is expected for this position.
Required Education & Experience
B.S. in Chemistry or Pharmaceutical Science, or other related discipline such as life sciences, drug product development.
Five to Seven (3 - 5) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC).
3 + years of experience in a regulated manufacturing or QC laboratory environment of analytical methods for pharmaceutical products
Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment.
Solid understanding of GMP compliance, Quality Control CMC requirements for ANDAs, and other regulatory filings
Excellent interpersonal, verbal, and written communication skills
Demonstrated collaborative skills and prior leadership roles or positions
Comfortable in a fast-paced, small company environment, ability to adjust workload based upon changing priorities
Technical knowledge
Strong Microsoft Word, Excel, and Office skills
Experience in contracting testing laboratories
Preferred Experience & Experience
BS in relevant life science, scientific, or engineering discipline
Three to Five (3 - 5) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC).
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. All duties, responsibilities, and activities may be subject to change at any time with or without notice.
EEO Statement:
Tedor Pharma, Inc. is proud to be an Equal Employment Opportunity and Affirmative Action employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminated based upon race, religion, color, marital status, national origin, gender, sexual orientation, gender identity, gender expression, age, status as a protected veteran, ancestry, medical condition, pregnancy, genetic information, status as an individual with any mental and/or physical disabilities, or any other status protected under federal, state, or local law.
Chemist
Chemist Job 34 miles from Pawtucket
We are currently seeking a Chemist I position in Quality Control to join our team. The Chemist I will perform general compendial testing of product and/or raw materials within a fast-paced cGMP environment. Additional responsibilities will include reagent preparation and routine equipment maintenance activities. Laboratory experience is required.
Key Responsibilities Include:
· Performs test methods as written to support product/material release.
· Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements.
· Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance with procedural requirements.
· Performs a multitude of laboratory techniques for which they are trained.
· Accepts responsibility to complete assigned tasks within required timelines and works with others to accomplish business objectives.
· Revises procedures as necessary and provides continuous improvement support for the department.
· Support laboratory investigations in a timely manner.
· Support a variety of testing techniques upon completion of training.
Basic:
· BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree
and 1+ years of related work experience.
· Solid understanding of cGMP and quality control and documentation requirements.
Preferred:
· Spectrophotometric concentration determination
· Experience testing Appearance per USP, EP requirements
· Quality Control testing of phase III and commercial products
QC background
Documentation
Advance testing/CE-SDS, HPLC or ELISA experience
Empower or Softmax / PLA software experience is a plus
BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree and 2+ years of related work experience.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Senior Chemist (Technical Manager)
Chemist Job 34 miles from Pawtucket
** Candidates must be authorized to work in the U.S. without current or future visa sponsorship. Sponsorship is not available for this position.
Are you a creative and results-driven lead chemist with a passion for developing innovative plastic formulations? Do you thrive in a fast-paced environment, collaborating with R&D, production, and customers to deliver high-performance plastic solutions? If so, we want to hear from you!
Location: 30 minutes north of Worcester
Why Join Us?
Be part of a rapidly growing and innovative plastics manufacturer.
Work on cutting-edge polymer formulations with industry-leading experts.
Opportunity to make a direct impact on product development and customer success.
Collaborative, fast-paced, and dynamic work environment.
Key Responsibilities:
Develop and optimize plastics formulations to meet customer requirements and improve first-pass acceptance rates.
Manage multiple customer sample requests and ensure timely delivery within R&D lead times.
Collaborate with operations and manufacturing to scale up new products and optimize production processes.
Provide technical support to sales teams and customers, including product recommendations and troubleshooting.
Maintain R&D records, formulations, and testing data while ensuring compliance with quality and environmental standards.
What You Bring:
5+ years of hands-on experience in plastics or compounding formulation development, including processing and performance optimization. And the ability to take on progressively challenging responsibilities, with opportunities for professional growth and advancement within the organization. We will consider a manager-level candidate for this role.
BS in Plastics, Materials Science, or related
Ready to lead in a growing, innovation-focused environment? Join us and bring your expertise to a company rooted in quality, teamwork, and the future of plastics manufacturing. EOE
Keywords
:
chemist, scientist, technical manager, chemical, polymer processing, resin handling, blending, extrusion operations, pelletizing systems, injection molding, thermoplastic materials, color, additives, plastics, advanced materials, engineered polymers, paint, coatings
Oligonucleotide Chemist
Chemist Job 38 miles from Pawtucket
PRIMARY RESPONSIBILITIES :
Be responsible for the day-to-day work and management of the Oligonucleotide teams in Boston
Design and implement innovative strategies for the synthesis, purification, and scale-up of oligonucleotides
Utilize hands-on experience to optimize synthetic routes, purification methods, and bioconjugation protocols
Conduct analytical characterization using HPLC, LC-MS, and other analytical methods.
Complete the goals associated with specific oligonucleotide process optimization projects.
Develop solutions and providing recommendations as to the appropriate course of action to technical problems associated with the preparation of synthetic oligonucleotides.
Provides documentation and validation support in execution of synthesis and/or purification process changes.
Performs laboratory work and documentation in accordance with regulatory standards and company guidelines.
Mentor oligo team members, providing technical guidance and expertise in oligonucleotide chemistry
EDUCATION AND EXPERIENCE:
Minimum of a Master Degree in Biochemistry, Chemistry, Molecular Biology or related discipline.
Minimum of 5 year of industrial or academic experience in the synthesis and purification of oligonucleotides.
Excellent understanding of the basic structure and function of DNA and RNA, including but not limited to advanced applications such as gene cloning, NGS preparation.
SKILL REQUIREMENTS:
Competence & Skills
Experienced in high-throughput oligonucleotides synthesis, proficient in the operation of the 192&768 synthesizer, and carry out simple instrument troubleshooting and repair.
Proficient in multiple analytical and purification techniques for DNA/RNA oligonucleotides to ensure that the purity and quality of oligonucleotides meeting experimental requirements.
Experienced in the application of LC-MS technology for accurate qualitative and quantitative analysis of nucleotides.
Knowledge of commonly used biomolecular analysis methods (e.g. qPCR, DNA sequencing) or relevant practical experience.
Knowledge of the downstream application of oligonucleotides, like gene synthesis, molecular cloning, NGS, etc.
Professional Attitude
Good scientific thinking and innovation ability, able to independently design experimental programs and promote project progress.
Good teamwork spirit, able to communicate effectively with other researchers and solve research problems together.
Strong willingness to learn and ability to quickly adapt to new technologies and methods.
Welcome challenge and extra responsibilities.
With clear career aspiration and willing to make impact to the environment.
Chemist - II
Chemist Job 34 miles from Pawtucket
Seeking a Chemist II position in Quality Control to join our team. The Chemist II will perform laboratory testing within a fast-paced cGMP environment. Experience with capillary electrophoresis testing is required.
Responsibilities:
Performs test methods validations for clinical and commercial projects.
Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements. Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance with procedural requirements.
Performs a multitude of laboratory techniques for which they are trained.
Accepts responsibility to complete assigned tasks within required timelines and works with others to accomplish business objectives.
Authors validation protocols and reports as well as corresponding test methods.
Support laboratory investigations in a timely manner.
Support a variety of testing techniques upon completion of training
Experience:
2+ years of related work experience.
Skills:
QC background
Documentation
Advance testing/CE-SDS, HPLC or ELISA experience
Empower or Softmax / PLA software experience is a plus
Education:
BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree.
Ravi Sharma
Recruiter
Scientific and Clinical Division
****************
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10 Exchange Place, Jersey City, NJ 07302, USA
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Analytical Scientist
Chemist Job 44 miles from Pawtucket
Nextcea Inc. is currently seeking multiple full-time entry-level Analytical Chemists. Qualified candidates will actively participate in LC-MS analysis at Nextcea. Successful applicants should hold a BS/MS (for Associate Scientist position) or a PhD (for Scientist position) in Analytical Chemistry or a related field, along with relevant laboratory experience. While experience in LC-MS is preferred, it is not required.
We seek self-motivated candidates who are excellent team players and can contribute to established laboratory procedures and protocols. Candidates must be able to work independently, be flexible, and adapt to challenging biomarker projects related to drug efficacy and safety assessments in late-stage drug development and clinical trial studies.
Nextcea is a pharmaceutical service company that provides biomarkers for drug efficacy and safety assessments in nonclinical and clinical studies.
At Nextcea, we believe in the power of diversity and inclusion. We offer competitive compensation and benefits, including medical, vision, dental, and 401(k), to all our employees, regardless of their background or identity.
So that you know, candidate phone calls are not acceptable. To apply, either go online at LinkedIn or email your resume or CV to **************.
Scientist/Associate Scientist, In vivo pharmacology
Chemist Job 38 miles from Pawtucket
A well-funded and highly innovative start up from Third Rock Ventures is emerging out of stealth with a syndicate of marquee investors and is seeking a talented Scientist/Associate Scientist (AS) to join the Biology-In vivo pharmacology team. The Scientist/AS will support the in vivo pharmacology team for discovery-stage pipeline program(s) focused on antibody-driven diseases. The role will work collaboratively with the Biology team lead(s) to contribute to lead characterization and development candidate selection. The Scientist/AS will aid in the management of both external and internal in vivo pharmacology studies and contribute to the growth of internal in vivo capabilities. The ideal candidate is an experienced lab-based biologist with a background in immunology and biologics drug discovery.
Responsibilities:
Design and carry out
in vivo
biology experiments that support preclinical drug discovery including PK/PD analysis, mechanism of action studies, and disease modeling
Aid in expanding our internal
in vivo
pharmacology capabilities at a shared vivarium space, including animal handling, dosing, sample collection/processing
Independently develop and execute quantitative assays for the analysis/characterization of
ex vivo
samples (ELISA, flow cytometry, etc.)
Work collaboratively with peer team leads to advance program(s) to IND
Proactively review literature to bring in newest scientific findings, ideas, and methods/technologies for discovery research
Manage out-sourced CRO-based workflows, including study design and data analysis
Required qualifications and experience:
PhD with 0-3 years or a Bachelors with 8+ years or Masters with 6+years in relevant scientific area, such as immunology, cell/molecular biology with
Experience in the design and execution of
in vivo
studies (experience assessing pharmacokinetics/pharmacodynamics of biologics preferred)
Experience with
ex vivo
sample analysis and data interpretation (ELISA, immunophenotyping)
Capacity to work within a dynamic matrix environment, with strong contributions to project strategy and execution
Excellent communication, presentation, and inter-personal skills; superb organizational and problem-solving skills
Sr. Quality Control Analyst
Chemist Job 36 miles from Pawtucket
About Us
Pace Life Sciences
Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Job Description SUMMARY
Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions.
ESSENTIAL FUNCTIONS
Serves as a lead to staff to include providing work direction, guidance, and training.
Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information.
Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.
Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
Provides training and guidance on analytical tests, methods, and instrumentation, as required.
Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.
Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others.
Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products.
Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
QUALIFICATIONS Education and Experience
Bachelor's degree in chemistry/biochemistry, or a closely related field.
Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred.
Required Knowledge and Skills Required Knowledge
Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development.
Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures.
Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns.
Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations.
Understanding of broad testing tools, equipment, and calibration.
Computer applications and systems related to the work.
Principles and practices to serving as an effective project team member.
Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
Correct business English, including spelling, grammar, and punctuation.
Required Skills
Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas.
Overseeing and administering broad and varied chemistry/biochemistry/formulation functions.
Ability to operate and train others in analytical instruments and manufacturing equipment.
Training others in policies and procedures related to the work.
Serving as a team member and the development and management of projects.
Operating in a both a team and individual contributor environment.
Interpreting, applying, and explaining applicable laws, codes, and regulations.
Preparing advanced to expert functionals reports, correspondence, and other written materials.
Using initiative and independent judgment within established department guidelines.
Using tact, discretion, and prudence in working with those contacted during the work.
Performing effective oral presentations to large and small groups across functional peers and the department.
Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
Establishing and maintaining effective working relationships with various individuals contacted in the work.
Additional Information
Benefits
80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer
Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Work Schedule Monday-Friday, 8:00am-5:00pm
Food Scientist
Chemist Job 33 miles from Pawtucket
BS in Food Science/Engineering/related science or engineering field
Internship in related field or applicable food processing technology and statistical process experience. MS/PhD in Food Science/Engineering/related science or engineering field
Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering. Product development experience. Problem solving skills.
Ability to work with cross-functional teams at multi levels within the organization.
Excellent interpersonal, communication skills. Accept feedback. Flexible and resilient.
1. Conduct research including new product research and the development of foods.
2. Develop new and improved methods and systems for food processing, production, quality control and packaging.
3. Work in pilot plant and support production scale ups and commercializations.
4. Field customer requests both internal and external to satisfy project needs from a conceptual phase through commercialization and troubleshooting.
• Participate in ideation/brainstorming
• Develop gold standards while working with Culinary and subject matter experts (SMEs)
• Match competitive products
• Formulation Optimization
• Concept to Commercialization
• Execute internal processes
• Ability to understand and troubleshoot customer processes
5. Be a strong part of customer facing team to deliver solutions that will “Nourish and Delight” our customers.
6. Coordinate customer calls with sales/culinary representatives through presentations both technical and culinary based.
7. Work with cross functional groups to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers
8. Develop and protect Intellectual Property by documenting research notes.
9. Study methods to improve quality of foods such as flavor, color, texture, nutritional value, convenience, or physical, chemical, and microbiological composition of foods
10. Complete project requests within the time frame required by the customer.
11. Employ efficient time management
12. Assist customers with technical issues that may arise.
13. Travel to Kerry production plants and to customers.
14. Must be able to taste and smell chemicals, flavors and food products.
15. Must be able to stand for long periods of time in a laboratory setting and lift 50 pounds.
16. Excellent verbal and written communication skills.
17. Must work well in teams.
Associate Scientist - Scientist I, Antibody Production
Chemist Job 37 miles from Pawtucket
Nona Biosciences is seeking a highly skilled and experienced scientist to join our team in Natick, MA. The successful candidate will play a critical role in establishing antibody discovery and production capabilities in our US lab. The main responsibilities of this role include designing, producing, purifying, and analyzing antibodies to support all projects. The ideal candidate should have hands-on experience with CHO and 293 cell culture and transfection techniques, as well as expertise in antibody purification.
Responsibilities
Design and source DNA constructs used for antibody expression.
Perform plasmid transfection in mammalian cells (CHO or HEK293) for antibody expression.
Antibody or other biologics purification by the affinity chromatography.
Characterize and quality control of purified antibodies using variety of analytical methods (SEC, SDS-PAGE, FACS etc.)
Maintain a detailed and well-organized record of experiments in electronic notebook.
Collaborate with other team members to support internal and external projects
Help organize, maintain and supply the laboratory
Requirements
BS./M.S. in biochemistry, molecular biology, protein chemistry or related fields.
2+ years of hands-on experience with mammalian cell culture and recombinant mammalian protein expression, such as CHO and HEK293 cells.
Experienced with protein purification techniques, such as affinity chromatography and SEC.
Knowledge with protein characterization and quality control techniques, such as protein concentration measurement, SDS-PAGE, Western blot, and ELISA.
Excellent organization/planning skills to meet deadlines and handle multiple tasks simultaneously
Diligent, self-motivated, independent and strong sense of responsibility
Good interpersonal skills for building relationships across functions internally and externally
Associate Scientist - Upstream Process Development
Chemist Job 30 miles from Pawtucket
Responsible for the execution and analysis of experiments and analytical procedures.
• Display an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures.
• Investigate basic technical problems and performs routine scientific procedures and experiments under general supervision.
• Plan and prioritize concurrent experimental procedures.
• Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results.
• May provide oral presentations on results to other department members.
• Work under active supervision.
• Follow established procedures.
• Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.
• Contribute to the completion of milestones associated with specific projects.
• Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources.
• Weekend work might be needed
• Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.
• Years of Experience: 1 - 3 Years.
• Minimum of Bachelor's degree required in related field.
Must-Have:
• Some professional post-graduation experience is required, 1 - 3 Years
• Microbial or mammalian cell culture experience
• Experience with MS Office (data entry ability to plot data)
• Motivated and Team Player
Nice to Have:
• Experience with aseptic techniques
• Biotech experience a plus
• Upstream cell culture
Organic Chemist
Chemist Job 34 miles from Pawtucket
Support Research and Development of new additives and formulations used in electroplating products for the electronics industry
Polymer synthesis and characterization
Help design and execute experiments involving equipment and instrumentation for electroplating of metals, electrochemistry, chromatography, microscopy, X-ray diffraction, material and mechanical testing, and additive synthesis.
Handle and mix plating bath components and additive solutions at both small and intermediate scales
Collect, analyze, and summarize data with appropriate documentation
Strict adherence to enhanced safety protocols and ability to work safely and participate in all group safety activities
Required Qualifications
Bachelor's degree in chemistry or related discipline
Demonstrated ability to handle wet chemistry and operate standard chemical and analytical instrumentation and equipment.
Highly motivated and effective at working both individually and within team environment to accomplish tasks and project goals
Preferred Requirements
Organic, inorganic, materials chemist
Experience with polymer synthesis
Experience with plating bath formulation, electrochemistry, or electrodeposition.
Experience with analytical techniques including X-ray Diffraction (XRD), cyclic voltammetry, and NMR.
Strong knowledge and demonstrated use of statistics and design of experiments (DOE) principles.
Thanks
Quality Control Analyst III
Chemist Job 12 miles from Pawtucket
Industry: Pharmaceuticals
Title: Quality Control Analyst III
Duration: 08 months contract (+Chances of extension)
2 openings - 1 Micro QC, 1 Chemistry QC
This position is onsite and will be primarily located in Norton, MA, with potential occasional responsibilities at other client locations. The role requires flexibility for weekend coverage to support a continuous operational schedule. This is a first shift position Friday-Monday (4 x 10 hours), but will require an initial period of Monday-Friday work to accommodate training.
Overview
The Quality Control Operations (QCO) Analyst III Contractor plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to executing routine and non-routine testing in support of development through commercial programs, the Analyst III will also participate in data trending, investigations, and laboratory operations. This position will also play a role in method transfers, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed with precision, the Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.
Key Responsibilities (including but not limited to):
• Perform routine and non-routine analytical and/or microbiological assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
• Support a continuous operational schedule by supporting weekend laboratory operations (Analytical, Microbiology, Raw Materials).
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
• Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
• Ensure data are reviewed timely; qualify as a data reviewer to ensure timely and efficient data availability.
• Perform role-specific operational assignments (e.g., raw material processes including SAP transactions, environmental monitoring, in-process testing, etc.).
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.
• Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective company goals
• Pursue ongoing training and development to deepen expertise in QC testing techniques, TOQ operations, and regulatory compliance.
• May assist in preparing technical documentation for regulatory submissions by performing data verification, ensuring accuracy and compliance with regulatory standards.
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Collaborate with other organizational functions including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance to ensure alignment with overall business goals.
Qualifications
• B.S. in chemistry, biology, or biochemistry, or related scientific field;
• Pharmaceutical/Biotech industry experience with 4 years in a GMP Quality Control function or equivalent, relevant industry experience
• Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach is desirable
• Demonstrated technical writing skills, with preference for technical writing of investigations
• Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making
• Solid problem-solving skills and experience in conducting investigations and implementing CAPA
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred
Quality Control Analyst III
Chemist Job 12 miles from Pawtucket
Quality Control Analyst III - Contract - Norton MA
Proclinical is seeking a dedicated Quality Control Analyst III to support the department's commitment to maintaining high standards of quality and compliance from development through commercialization.
Primary Responsibilities:
This role will be involved in routine and non-routine testing, data trending, investigations, and laboratory operations. This position requires flexibility for weekend coverage and is primarily based onsite in Norton, MA.
Skills & Requirements:
Degree in chemistry, biology, biochemistry, or related scientific field.
Experience in a GMP Quality Control function within the pharmaceutical/biotech industry.
Knowledge of method transfer and analytical method implementation.
Strong technical writing skills, particularly for investigations.
Proficient in data analysis and interpretation with attention to detail.
Problem-solving skills and experience in conducting investigations and implementing CAPA.
Strong organizational skills and ability to manage multiple tasks.
Excellent communication and teamwork abilities.
Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.
The Quality Control Analyst's responsibilities will be:
Conduct routine and non-routine analytical and microbiological assays for raw materials, in-process samples, product release, and stability studies.
Support weekend laboratory operations to maintain a continuous operational schedule.
Maintain training records, adhere to testing schedules, and ensure timely completion of assignments.
Assist in maintaining laboratory equipment and inventory, including reagent and sample preparation.
Review data promptly and qualify as a data reviewer for efficient data availability.
Perform operational assignments such as raw material processes and environmental monitoring.
Contribute to revising and updating controlled documents to ensure compliance with industry standards.
Adhere to internal and regulatory standards to maintain quality and compliance.
Participate in continuous improvement efforts to enhance laboratory processes.
Collaborate with QC and cross-functional teams to support seamless operations.
Pursue ongoing training to deepen expertise in QC testing techniques and regulatory compliance.
Assist in preparing technical documentation for regulatory submissions.
Participate in inspection readiness activities and support audits and inspections.
Collaborate with other organizational functions to align with business goals.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Senior Analyst I, Quality Control Chemistry
Chemist Job 44 miles from Pawtucket
Our Life Sciences client is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA.
The Senior Analyst will specifically support the gene therapy program and will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs).
Responsibilities
Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)
Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).
Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods.
Method Transfer / Validation of QC chemistry methods at internal and external laboratory.
Model leadership behaviors and mentor/train junior staff
The job responsibilities may change as needed to support activities relevant to the clinical phase.
Qualifications:
Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.
Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred.
Experience working with external contract labs (CMOs, CROs) is a plus.
Strong collaboration and team-working skills.
Strong communication, interpersonal and organizational skills.
Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
QC Analyst II, Flow Cytometry & Molecular
Chemist Job 25 miles from Pawtucket
WHO WE ARE
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
The QC Analyst II, Flow Cytometry & Molecular Team, will be executing analytical method transfers to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring Standard Operating Procedures (SOPs) and Test Methods. He/she will be executing various quality control methods, analyzing data, and reporting data. He/she will assist in the implementation of new assay methodologies and the associated instrumentation. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.
HOW YOU WILL MAKE AN IMPACT
• Perform routine and non-routine quality control testing on in-process samples and finished products.
• Operate and maintain laboratory equipment and instruments,
ensuring proper calibration and adherence to cGMP
Compliance.
• Provide support for method transfers/qualification/validation and stability testing.
• Support analytical equipment installation and qualification
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Author, review, and/or approve SOPs, Test Methods, and other procedures required to operate a QC laboratory.
• Participate in internal and external audits, inspections, investigations, change controls and CAPAs
• Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.
• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
• Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
• Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Communicate effectively with cross-functional peers, and department management.
WHAT YOU WILL BRING
• Bachelor's Degree in scientific discipline.
• 3+ years of relevant experience in cGMP Quality Control Laboratory.
• Hands-on experience with various analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs, cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods.
• Hands-on experience with Raw Material sampling or system management is a plus.
• Experience with rapid microbiological methods is a plus (e.g. mycoplasma)
• Knowledge of cGMP/ICH/FDA regulations.
• Ability to independently prioritize/manage activities.
• Ability to prioritize objectives from multiple projects and adhere to
scheduled timelines while maintaining flexibility and attention to
detail.
• Proficient in MS Office applications and information technologies that support documentation and data management systems.
• Strong troubleshooting, problem-solving skills, oral and written skills.
• Ability to multi-task and interact with multiple groups in a team-oriented environment.
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
Quality Control Analyst
Chemist Job 38 miles from Pawtucket
Title : Quality Control Analyst
Duration: 12 Months
Pay Range : $35.00/ Hr to $ 40.00/ Hour on W2
The Quality Control Operations (QCO) Analyst III Contractor plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to executing routine and non-routine testing in support of development through commercial programs, the Analyst III will also participate in data trending, investigations, and laboratory operations. This position will also play a role in method transfers, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed with precision, the Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.
Key Responsibilities:
• Perform routine and non-routine analytical and/or microbiological assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
• Support a continuous operational schedule by supporting weekend laboratory operations (Analytical, Microbiology, Raw Materials).
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
• Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
• Ensure data are reviewed timely; qualify as a data reviewer to ensure timely and efficient data availability.
• Perform role-specific operational assignments (e.g., raw material processes including SAP transactions, environmental monitoring, in-process testing).
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.
• Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective Alnylam goals
• Pursue ongoing training and development to deepen expertise in QC testing techniques, TOQ operations, and regulatory compliance.
• May assist in preparing technical documentation for regulatory submissions by performing data verification, ensuring accuracy and compliance with regulatory standards.
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Collaborate with other organizational functions including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance to ensure alignment with overall business goals.
Qualifications:
• B.S. in chemistry, biology, or biochemistry, or related scientific field;
• Pharmaceutical/Biotech industry experience with 4 years in a GMP Quality Control function or equivalent, relevant industry experience
• Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach is desirable
• Demonstrated technical writing skills, with preference for technical writing of investigations
• Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making
• Solid problem-solving skills and experience in conducting investigations and implementing CAPA
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred