Chemist Jobs in Metuchen, NJ

QC Chemist Job Title: Quality Control Laboratory Chemist - Radiopharmaceuticals Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Job Description: We are seeking a highly skilled and experienced Quality Control Laboratory Chemist to join our team in the Radiopharmaceuticals division. This critical role involves the quality control processes documentation development, analytical methods improvement, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in the pharmaceutical or radiopharmaceutical industry, a strong background in analytical chemistry, and well development technical writing capabilities. Key Responsibilities: Develop, optimize, and validate analytical methods for testing radiopharmaceutical products, including HPLC, GC, and TLC techniques. Troubleshoot and resolve issues related to laboratory equipment, ensuring proper functioning and accurate results and offering expertise and executing tasks related to department objectives and quality initiatives. Support the validation of analytical procedures, ensuring they meet internal specifications and regulatory requirements. Write, develop, and analyze methods and protocols for new and existing testing procedures. Serve as a key resource for the team, providing client support and managing communications related to reports, calls, and project updates. Contribute to the development of QC-specific protocols and reports, particularly for analytical method validation and related documentation. Collaborate with cross-functional teams and assist with the execution of client-driven requirements, ensuring that testing processes are aligned with regulatory standards. Lead and support efforts in continuous improvement projects that aim to optimize laboratory processes, increase efficiency, and enhance the overall quality system. Assist with departmental initiatives, including recruitment, training, and development of team members, as well as contributing to team scheduling and resource management. Ensure the accurate documentation of all testing results, protocols, and reports in compliance with GMP, GLP, and other regulatory guidelines. Qualifications: 5+ years of experience in the pharmaceutical, life sciences, or radiopharmaceutical industry Bachelor's degree in a scientific field (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences), or equivalent relevant work experience. Extensive experience with laboratory techniques, including HPLC, GC, and TLC, with a strong ability to troubleshoot and resolve issues related to these methods. Proven ability to develop, modify, and validate analytical methods for a variety of testing procedures. Strong written and verbal communication skills, with experience developing and writing technical reports, protocols, and validation documents. Demonstrated ability to work independently as well as collaborate effectively with cross-functional teams. Experience in supporting client needs, including providing timely updates, addressing inquiries, and delivering high-quality reports. Knowledge of GMP, GLP, and other regulatory requirements for pharmaceutical testing and documentation. Working Environment: Laboratory setting with exposure to radiation and other chemical hazards. Fast-paced laboratory setting with responsibility for multiple concurrent projects and tasks. Opportunity to contribute to team improvement, including process optimization and team development. Collaborative environment with a focus on innovation and continuous growth in the radiopharmaceutical sector.

"Education Requirements" B.S. in Chemistry required M.S. or Ph.D. in Organic or Medicinal Chemistry strongly preferred Job Title: Regulatory Chemist - CMC Documentation Duration: 6-month Contract (W2) Possibility to extend Job Description: This position requires a minimum of 50% onsite presence. The role focuses on compiling detailed information from scientists, authoring the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory documents, and conducting data integrity checks to support the timely submission of both investigational and marketing applications for small and large molecules. A solid understanding of organic chemistry principles and the ability to critically evaluate analytical data are essential for success in this position. Experience with drug substance and/or drug product CMC development is highly preferred. Key Responsibilities: Author and compile CMC sections of regulatory submissions, ensuring accurate and comprehensive documentation. Perform data integrity checks to support regulatory applications for investigational and marketing approvals. Collaborate with scientists and cross-functional teams to gather and assess relevant data. Utilize computer-assisted tools for document preparation to ensure quality and compliance with regulatory standards. Qualifications: Strong Regulatory Documentation and Authoring experience (not limited to formatting). A mandatory B.S. in Chemistry is required, with M.S. or Ph.D. in Organic or Medicinal Chemistry strongly preferred. In-depth understanding of Organic Chemistry and Medicinal Chemistry. Excellent written and verbal communication skills with attention to detail. Ability to multitask and work collaboratively within a team-oriented environment. A background in pharmaceuticals is essential, particularly in drug substance or drug product CMC development.

Job Details: Chemist Global Pharmaceutical Company Contract, Long Term Will start in Skillman, NJ and move to Summit, NJ in the summer Pay up to $33-34/hr The Scientist, Analytical Advanced Models and Methods is responsible for planning and conducting moderately complex experiments, analyzing results, and providing solutions to problems of moderate complexity. You will also keep accurate records, review case report forms, and present data at in-house meetings: Key Responsibilities Develop advanced analytical models and methods to solve complex scientific problems Utilize innovative techniques to analyze data and generate insights Collaborate with cross-functional teams to design and implement cutting-edge solutions Stay current with industry trends and advancements in analytical methodologies Conduct in-depth research in assigned areas using cutting-edge methodologies Analyze and interpret complex data to provide actionable insights Continuously explore and integrate new technologies to enhance analytical capabilities Present findings and recommendations to stakeholders in a clear and compelling manner Present findings and recommendations to stakeholders in a clear and concise manner Qualifications What we are looking for Required Qualifications Bachelor's Degree in Chemistry, Materials Science or equivalent in a related field 2-4 years of experience in developing analytical models and methods using instrumentation techniques such as SEM, DSC, TGA, HPLC, UPLC, FTIR, LC/MS and GC/MS Proven track record of developing and implementing analytical solutions Strong proficiency in statistical analysis and data visualization tools Ability to think critically and problem-solve creatively Excellent communication skills and ability to work effectively in a team environment Desired Qualifications Experience with chemometrics and statistical tools such as PCA, PCR, and PLS Experience with programming languages such as Python, SAS, MATLAB Strong understanding of statistical methods and machine learning algorithms Experience with formulation chemistry across a wide variety of product types (e.g. emulsions, suspensions, solid oral dosage forms)

RESPONSIBILITIES: Must be able to perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs. Must record data and results as specified in documentation procedures. Documents work clearly and perform tests accurately. Must comply with regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. Must prepare and review the analytical documents. Associate Chemist II will be responsible to prepare and/or Review Test Procedures, SOPs, and Protocols as assigned Responsible for maintaining independent verification testing programs with 3rd party contractor. Perform routine laboratory analysis, such as finished product testing, dissolution testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Must provide the necessary document to Support for the ANDA filing Associate Chemist II must perform troubleshooting and investigations under the direction of a supervisor/senior QC chemist. QUALIFICATIONS: Must have BS with chemistry 3+ years of experience as associate chemist in pharmaceutical industry. QC experience in Generic pharmaceutical industry. Must have good documentation practices. Knowledge in USP/ICH/FDA. BENEFITS: Medical Insurance Dental Insurance Vision Insurance Contract to Hire

Specialty paint, coatings, and additives company is looking for a Coatings Chemist with application development experience. The position is located in Fairfield, NJ Responsibilities: Solve customer problems by applying our additives to the customer coatings problems. The employee is primarily responsible for working in a lab to test and evaluate those solutions Explore R&D teams new additives for potential applications Daily working on the bench Spraying and testing of formulations Extensive tracking of data Work from formulation to plant scale up. Interact with internal and external customers. Requirements The employee must have at least a Bachelor's degree in Chemistry. Masters or PHD is a plus. 5 years Coatings work experience is required Confident working in a lab Strong Application Development skills Strong organization skills are important to effectively manage the wide range of responsibilities. The employee must be able to clearly and effectively communicate in person and in writing. PLEASE NOTE THIS POSITION IS LOCATED IN FAIRFIELD, NJ. Relocation Assistance is provided.

Job Title: Process Chemist Department: Process R&D Job Type: Full Time Director of Process Chemistry We are seeking a highly motivated and skilled Process Chemist to join our Process R&D Department at Porton J-STAR. In this role, you will be responsible for the development, optimization, and scaling of chemical processes for pharmaceutical production. You will collaborate with cross-functional teams to ensure that our processes are efficient, cost-effective, and compliant with regulatory standards. This job description applies to activities and responsibilities associated with the process chemistry development group and support of GMP Operations. Responsibilities Follow existing synthetic routes, making processing improvements where necessary, while conducting multi-step organic synthesis Plan and organize routine operations to maximize production output. Design novel synthetic routes and carry out multi-step organic synthesis. Operate simple open access HPLC/UV, LC/MS, MS, NMR, GC/MS, and other analytical instruments required to monitor reaction processes. Consult with management, the Analytical Department, the Director of GMP Operations and others on issues concerning experiments prior to and during GMP production. Accurately make and check calculations, prepare raw materials, reagents and solutions in accordance with company SOP's. Faithfully record procedures and results in Batch Records or Solution Preparation Forms, notebooks, or other appropriate forms in an organized manner as dictated by departmental SOP and GMP regulations. Write reports on research as required. Promote compliance with cGMP regulations. Attend GMP training sessions. Support management and maintenance of the SOP and Document Control system. Work with clients to develop material release tests and specifications for materials supplied by J‑STAR. Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, GMP Operations and Quality Control. Conduct process chemistry R&D for clients as an individual contributor, which includes, but is not limited to, research on synthetic routes to active pharmaceutical ingredients and chemical intermediates by route discovery, process optimization, safety evaluation, enabling technologies, high throughput screening and chemo/biocatalytic reaction discovery and optimization. This will include R&D under c-GLP and potentially under c-GMP conditions. Develop safe, timely and efficient chemical processes by using established, new and/or novel chemical methodologies and processes. Coordinate analytical chemistry methodology to process and/or catalysis discovery, development optimization and problem solving. Maintain an uncompromising focus on quality, documentation, confidentiality and scientific execution. Participate in idea generation for selective quotes/proposals to clients as well as successfully execute against accepted quotes. Initiate cross-department communication and develop coordinated R&D, processing schedules and deliverables Lead and contribute to scientific and technical discussions with co-workers and clients to plan, execute, resolve issues and problem solve. Communicate candidly, clearly and timely with clients, management and peers. Participate in weekly client updates as needed, prepare weekly reports, contribute to and lead campaign reports and participate in process chemistry technology transfer. Coordinate and author professional campaign reports, research summaries, and tech packages. Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs. Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices. Maintain a clean and well-organized hood, bench, glove-box and common work area that is free of clutter, excess chemicals/samples. Advocate for these principals and positively influence others in this regard. Qualifications Required MS, PhD degree in Organic Chemistry. Proven track record meeting aggressive targets as related to safe, timely and successful synthetic organic chemistry projects. Knowledge and experience base of working in a c-GMP environment is preferable, but not required Excellent written, verbal and presentation skills. Experience in small molecule drug development is preferable, but not required. Track record of scientific success as measured by publications and presentations. Ability to prioritize and manage numerous activities simultaneously. Ability to interact in an effective and appropriate manner with diverse population sets. Experience in working on and positively contributing to scientific teams. Ability to perform the physical requirements of the position.

Perform chemical and physical testing for complex inhalation product formulations under general supervision. Conduct testing in a cGMP laboratory and document those experiments per cGMP requirements. Calculate, organize, and communicate results using standard data templates and reports. Provide general laboratory assistance including planning, designing and executing experiments. Edit SOPs, protocols, methods, and reports. Position Description: • Perform analytical testing for inhalation products according to established testing method, per cGMP requirements. • Analyze samples, process data and document in laboratory notebook. • Organize and maintain the functionality of the lab. • Edit SOPs, protocols, methods, and reports. • Plan, design, and execute experiments with guidance from supervisor/senior staff. Necessary Skills: • Possess good organizational skills, a commitment to quality work, and good oral and written communication skills. • Work effectively as part of a team. • Experienced with HPLC, GC, KF, FTIR, or other analytical instrumentation necessary.

Our client, a well-established company in the cosmetic and personal care industry, is looking for an Associate Chemist to join their team. This role operates fully onsite in their Clark, New Jersey location. Responsibilities: Assist with the formulation of cosmetic products, including batching, stability studies, and product evaluations. Conduct physicochemical characterizations, including pH, viscosity, rheology, and microscopy. Perform regulatory compliance assessments for raw materials and final formulations in alignment with industry standards. Operate lab equipment (e.g., rheometers, viscometers, microscopes) to assess product performance. Conduct quality control measurements and microscopic analysis. Required Qualifications: Bachelor's degree in Chemistry, Chemical Engineering, or a related scientific field. 0-3 years of professional experience in a laboratory environment (internships or academic projects in related fields are also considered). Previous experience in the cosmetic, pharmaceutical, or related industries is a plus. Strong proficiency in Microsoft Excel and other relevant computer programs. Experience with lab equipment (rheometers, viscometers, microscopes) is a plus. Ideal candidate will be quick learner, detail oriented with good communication skills and able to thrive in fast-paced team environment Strong attention to detail, organized, and methodical. If you meet the required qualifications and are interested in this role, please apply today. The Solomon Page Distinction Solomon Page offers a comprehensive benefit program for hourly employees. We pride ourselves on offering medical, dental, 401(k), direct deposit and commuter benefits to our employees, including freelancers - which sets us apart in the industries we serve. About Solomon Page Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: solomonpage.com and connect with us on Facebook, and LinkedIn. Opportunity Awaits.

Exemplify BioPharma, Inc. a Symeres Company is a global partner research organization (PRO) based in New Jersey, USA. We are a team of biopharma industry experts focused on delivering end-to-end Chemistry, Manufacturing and Controls (CMC) throughout the drug development and regulatory market application processes. Using a unique combination of program management, coupled with our New Jersey based R&D laboratories and GMP manufacturing facilities we are ideally positioned to deliver CMC success to partner organizations. We are talent based team and our key asset is our experience, multidisciplinary expertise and proven track record. We strive to bring tangible value to our partners through provision of strategic, tactical and technical leadership to solve complex problems focused on reducing program timelines and costs. The Role Exemplify is seeking an experienced Senior Analytical Chemist to join our dynamic drug development team. The ideal candidate will have a strong background in analytical chemistry and at least 3-5 years of experience in support of formulation development and GMP manufacturing of NCE's in the pharmaceutical industry. As a Senior Analytical Chemist, you will play a lead role in developing innovative products for our clients across various industries. Responsibilities Author and review technical documents including stability and validation protocols, specifications, test methods, Certificate of analysis/Report of analysis and other technical documents as needed. Complete method development, verification and validation including release and stability methods in support of preclinical and clinical development and activities. Perform method trouble shooting as required and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. Analysis of finished products, in-process materials, raw materials under cGMP. Perform stability testing on R&D and clinical batches and report/document per applicable specification and stability protocols. Collaborate with cross-functional teams including formulation scientists, quality assurance professionals, and regulatory affairs professionals to ensure timely and successful project completion. Interface with clients. Requirements A Ph.D. degree in analytical chemistry or a related discipline with at least 3-5 years of experience in analytical support of formulation development, manufacture and release. A demonstrated ability to conduct independent research, solve scientific problems, and lead other professionals in a highly collaborative environment. Experience working with solid oral dosage forms (tablet, capsule, solution, suspension), including various release formats IR, ER, DR etc. and topical formulations. Experience with parenteral formulation development is a plus. Demonstrated skills/expertise in analytical instrumentation including LC (HPLC, UPLC), KF titrators, dissolution, FT IR, UV-VIS, PSD, GC, LC-MS, XRPD. Demonstrated experience in method development, trouble shooting, and validation (HPLC, dissolution, GC, LC-MS) in support of NCE drug product development and release. Strong understanding of cGMP regulations and regulatory requirements for NCE drug development, including FDA, EMA, and ICH guidelines. Strong written and oral communication skills. Ability to manage multiple projects simultaneously. Excellent problem-solving skills and ability to work independently. Experience working with directly with external clients is a plus. Experience in pre formulation and solid state characterization is a plus. Experience in providing scientific support for regulatory submission (IND, IMPD) is a plus. Benefits Exemplify offers a competitive salary and total benefit package including health, dental, vision, life and short-term disability insurance through APD, including a 401K retirement saving's plan, and paid time off. Application This is an exceptional opportunity for motivated candidates who wish to be exposed to all aspects of CMC drug development in a fast moving, collaborative and learning environment. If you are interested in applying for this exciting opportunity at Exemplify BioPharma please e-mail a cover letter and resume to ******************************.

Job Title: Laboratory Scientist - Pharmaceutical Manufacturing Support Key Responsibilities :Routine Testing and Analysis : Conduct routine analysis of finished products and raw materials, including weight, chemistry tests for raw materials, and stability sample testing under different ICH conditions .Testing and Assays : Perform a range of tests, including assay, identity (ID), content uniformity, blending uniformity, impurity testing, water content determination, content resolution, disintegration, and hardness testing .Instrument Proficiency : Operate and troubleshoot laboratory instruments such as HPLC, UPLC, GC, Karl Fischer, FTIR, visualization testers, and pH meters. Experience with chromatography software (e.g., Empower 3) is highly preferred .Methodology Compliance : Follow approved testing procedures and methods according to internal SOPs and USP monographs. Report data accurately and promptly .Data Review and Trending : Conduct peer data reviews and analyze data trends to ensure consistent results. Participate in laboratory investigations using TrackWise software .Collaboration and Support : Assist other scientists and laboratory personnel to ensure timely completion of projects. Support routine lab activities such as balance calibration, pH calculations, and other day-to-day tasks .Stability and Medical Testing : Perform stability testing of pharmaceutical products and excipients under ICH conditions, and assist with medical testing as necessary .Software Utilization : Utilize Empower 3 chromatography software for HPLC and UPLC analysis . Position Requirement s:4-8 years of hands-on experience in a laboratory setting, with a focus on oral solid dosage forms (tablets, capsules, sub-gels) and raw material s.Strong working knowledge of pharmaceutical testing, including stability testing and compliance with USP standard s.Experience with laboratory instrumentation such as HPLC, UPLC, GC, Karl Fischer, FTIR, and pH meter s.Prior experience with Empower 3 software or similar chromatography software is a significant advantag e. Skills and Knowled ge:Strong understanding of pharmaceutical testing methods, including assay, identity testing, content uniformity, and impurity analys is.Knowledge of data review processes, trending, and documentation of test resul ts.Ability to adhere to SOPs, USP monographs, and GMP regulatio ns. We are looking for a candidate who is proactive, detail-oriented, and possesses a strong understanding of modern pharmaceutical testing methods. If you have a passion for contributing to the development of high-quality pharmaceutical products and have the required experience, we would love to hear from you.

Jacobs Levy is seeking a Senior Quantitative Equity Researcher for our Florham Park, NJ office with a strong background in technical computing and statistics to join our research team. The team is responsible for researching all aspects of the investment process from data processing and alpha modeling through to portfolio optimization. Our researchers work collaboratively to contribute to our firm's leading edge, innovative investment process. We seek people who are passionate about equity investment and motivated to outperform the market . Responsibilities include: Conducting exploratory data analysis Empirical research into U.S. and global equity market inefficiencies Reviewing financial literature Developing new and improving existing investment models by identifying novel investment ideas and innovative data sources Creating innovative investment strategies Ideal candidates will look to combine creative insights with research to make sound investment decisions. Requirements include: PhD in Finance, Econometrics, or related quantitative discipline Familiarity with fundamental, expectational and market data Solid knowledge of asset pricing literature Strong programming skills (C++, C#, Fortran, Java, Julia, Python etc.), preferably experienced with large datasets and also familiar with parallel programming Version control experience (such as Git) An understanding of Bayesian Statistics, Machine Learning, Non-Linear Estimation Methods, Optimization, Transaction Cost Modeling, or Data Visualization is a plus At least 3 years of empirical equity research experience Independent thinker with good economic intuition and demonstrated record of original research Ability to work collaboratively across departments and to explain challenging technical concepts

Adecco Healthcare & Life Sciences is currently recruiting experienced Laboratory Technicians for a global cosmetic manufacturing organization with over 100 years of innovation and success in the industry. Job Location: Clark, New Jersey, 07066 - Onsite-Candidates must reside within 1 hr of Clark, NJ Schedule: Monday through Friday, 8:00 AM - 5:00 PM Pay Rate-The anticipated wage for this position is between $ 22.75 to $22.94- Hourly wage depends upon experience, education, geographic location and other factors. Requirements: • Must possess a Bachelor's degree in Chemistry or a related scientific field • 4 to 6 years of relevant laboratory experience • Excellent communication and interpersonal skills Key Responsibilities: • Order raw materials and maintain inventory • Prepare and process experimental batches • Accurately record all experiments in laboratory notebooks • Perform and track stability testing on all formulated products • Interface with various internal support groups for testing and development needs. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility

This position is for an experienced scientist with significant skills and interests in bench-level technical work. The individual will be part of a successful team focused on delivering innovation. Conduct laboratory bench research in the area of chromatography and sample preparation. Primary activities include execution of technical work under general supervision of senior technical staff. This will include carrying out chromatography sample preparation and testing as well as basic method development in GC. The ability to develop technical approaches and plans, solve appropriate technical problems and work independently is also expected. This position will require development of a detailed understanding of chromatographic theory. Key Responsibilities: Plan, setup and execute experiments Analyze data, accurately document experiments, propose next steps Follow safe laboratory practices and keep areas clean Participate in Department meetings and other R&D facility activities Requirements BS in Chemistry with 1-5 years of industry experience, or fresh MS in chemistry. Preferred: Familiarization with Agilent OpenLAB and ChemStation GC software.

To be considered for this position, you must be authorized to work for any US employer without sponsorship now or in the future. will be working the overnight shift, Mon-Fri from 10PM to 6:30AM. The Opportunity: A New Jersey-based flavor and fragrance company is seeking an experienced Chemist with a strong background in organic and process chemistry to develop new products and processes for flavor and fragrance ingredients for the food and cosmetics industry. Successful applicant will have excellent theoretical and practical knowledge as well as experience in organic synthesis including synthetic methodology, catalysis, upstream and downstream processing. The position also requires conceptual design and experimental validation of designed processes. Qualifications: Bachelor or Master Degree in organic chemistry or related field Experience in distillation, re-crystallization, sublimation, deposition and extractions, synthesis Two years of industrial experience or related Knowledge of various lab equipment Ability to design, execute and troubleshoot experiments and processes Capacity to work independently Possess strong written and oral communication skills Ability to work effectively in a team environment and individually Physical fitness is required

Are you an experienced Scientist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Scientist to work at their company in Rahway, NJ. Our company's Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of Client biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection. The DPPD within our Company Research Labs is seeking a talented, self-motivated, and highly collaborative Scientist with knowledge of container closure integrity (CCI) technology and experience with test method development, testing, and method validation for various product images (vials, syringes, cartridges, and injectors) and secondary packaging. The candidate will develop methods for our company's combination product pipeline, inclusive of small molecule, biologics, and vaccine products. Primary Responsibilities/Accountabilities: Develop, validate, and execute feasibility CCI studies for complex combination devices & delivery systems Author technical reports and testing protocols Review technical data to ensure compliance with cGMP standards Collaborate with cross-functional teams to ensure successful tech transfer of analytical methods between QC labs Qualifications: B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with 2-4 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in container closure integrity methods. Relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity as it pertains to small molecule, biologics, and vaccine products. Ability to learn new techniques, troubleshooting assays, author and review technical documents Excellent organizational skills to manage multiple projects Preferred: Hands-on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis Familiarity with compression/tensile testing (Instron, Zwick, Texture Analyzer), rheology (TA Instrument), metrology/non-destructive inspection (XRCT [Zeiss], Optical microscopy [Keyence], high-speed imaging) Good technical, communication (oral and written), interpersonal, and teamwork skills. Ability to effectively identify and communicate risks. 100% lab based role. Buzz words: CCI, Container closure integrity, Vacuum decay, dye ingress, helium leak, laser headspace analysis, CO2 ingress, mass extraction, container validation, device verification, GMP, GXP, method development, method validation, USP , instron, medical device,tensile testing, auto-injectors, syringes, on-body injectors. Container Closure Integrity Testing: Closure integrity (CCI) is crucial for drug product sterility and stability. Container Closure Integrity Testing (CCIT), commonly referred to as leak detection, is a non-destructive packaging inspection system to maintain an aseptic barrier against potential contaminants.

QC Cell Therapy Scientist - Contract - Cranbury, NJ Proclinical is on the hunt for a bold, innovative thinker who is ready to help push the boundaries of science and make a tangible difference in the world. Primary Responsibilities: The successful candidate will be required to support the clinical and commercial manufacturing of gene therapy products. This role focuses on AAV and LVV gene therapies, requiring strong technical expertise in CGT analytical methodologies and excellent communication and collaboration skills. Skills & Requirements: Background in Biology, Molecular Biology, or Immunology. Experience in QC/GMP environments, preferably with gene/cell therapy products. Understanding of cGMPs and international regulations. Proficiency in cell and gene therapy assays and analytical characterization of viral vectors. Experience with mammalian cell culture and related activities. Ability to create, revise, and approve SOPs and reports. Experience in authoring and approving investigations for IA, OOS, and OOT results. Knowledge of method transfer, qualification, and validation. Strong analytical and problem-solving skills. Ability to work independently and make decisions. Effective in a fast-paced environment with a proactive attitude. The QC Cell Therapy Scientist's responsibilities will be: Conduct laboratory techniques such as q-PCR, dd PCR, ELISAs, Western Blot, and Infectivity assays in compliance with cGMPs. Perform routine testing for sample release and stability, ensuring timely reporting. Manage stability data mining and prepare data summaries. Review QC stability data and generate Certificates of Compliance. Execute laboratory protocols and prepare reports. Sub-culture mammalian cell lines and perform cell counts. Maintain laboratory reagents, supplies, and equipment. Qualify reagents, reference materials, and analytical techniques. Assist in planning and executing stability studies. Perform QC data review and generate CoAs for product release. Enhance knowledge of analytical techniques and procedures. Liaise with functional groups to progress projects and plans. If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@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.

Kilo Lab Technician - Ewing, NJ This position is to conduct activities towards synthesis of intermediates and API in kilo labs. Receives daily task assignments, under moderate supervision. Functions as a member of a work team by assisting others and promoting a team-oriented work environment. Performs all work in conformance with applicable regulations. Perform all work in a safe manner. Works within the laboratory or processing environment. Principal DutiesPerform operations under supervision with equipment setups and execution in the Kilo Lab and work in a fast-paced environment. Operations include charging (solids / liquids), extractions, filtrations, and drying. Assist with maintaining batch documentation necessary for the manufacture of Active Pharmaceutical Ingredients (API). Proactive and ensures readiness by participating in equipment preparation and cleaning of manufacturing equipment as defined in standard operating procedures (SOP). All responsibilities are guided by strict regulations, e.g., cGMPs, SOPs, and batch records; familiarity with the regulations is preferred but not required. Adhere to safety procedures and demonstrate safe work practices Demonstrate hands-on experience, equipment maintenance, troubleshooting, and mechanical aptitude skills and be able to work effectively with multiple assignments. Job QualificationsMust Have relevant experience. Associate degree in chemistry with at least 2 years of relevant experience preferred. Good written and verbal communication skills are required. Appropriate level of understanding of applicable regulations. Standing, bending, and lifting upward of 55 Lbs. may be required. Have worked in a laboratory environment. Demonstrates knowledge of performing scale-up operations. Ability to learn new technical skills and concepts. Concise and accurate reporting of technical data and information. Ability to troubleshoot technical problems.

Laboratory Technician Duration: 6months contract Pay Rate: $25.00/hr. Shift - 2nd shift - 4pm-10pm (swing Shift) Education: High School Diploma/GED required Bachelor's degree in chemistry preferred not required Skills: Sampling Stock Management QHSS&E Sampling Compounds fragrance oils as per business priorities and due delivery dates applying global good laboratory practices, standard operating procedures, supported with the digital tools and software's available Delivers the minimum required average nb of manual pours/day as per the global target and the target defined by the creation lab manager (excluding pours that could have or should have been tasked to the robot, except where specifically authorized) Optimizes the number of pours to be done manually when applicable Stock management QHSS&E Ensures compliance with all QHS&E procedures and proactively contributes to the improvement of lab safety Maintains a clean and well-organized laboratory/workplace Ensures all samples produced meet the quality standards as per the global SOPs before releasing the samples Continuous improvement and efficiency Adopts a culture of continuous improvement, and actively participates in LEAN projects Operates with a team spirit mindset and supports the colleagues under high workload situations

Our client, a global leader in personal care and household products, is seeking a Laboratory Technician to join their growing team. This is a great opportunity to work with one of the world's fastest growing consumer packaged goods companies. Location: Mercer County, NJ Pay: Up to $22/hr Type: Contract, possibility of extension Responsibilities Develop and formulate consumer products, ensuring accurate measurements of key properties such as pH, specific gravity, and viscosity. Perform thorough stability testing to assess product longevity and reliability under various conditions. Conduct product performance evaluations to determine efficacy and assess fragrance quality through evaluations by test panels. Maintain comprehensive records of all tests, results, and observations, while also ensuring cleanliness and organization within the lab environment. Execute all necessary testing relevant to the product care category within the product group, ensuring that each product meets the required standards and specifications for quality and performance. Requirements Bachelor's degree in Chemistry, Biology, or a related field. Laboratory experience is preferred (can be gained through academic coursework). Experience with wet chemistry techniques (such as pH, viscosity, titrations, etc.) is preferred. Strong work ethic with a keen attention to detail. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!