- UpvoteDownvoteShare Job
- Suggest Revision
Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry. Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance. Previous experience in a cGMP laboratory. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
B.S. with 4 years, or M.S. with 3 years or PhD with 0+ years of relevant experience (or expected PhD graduation within 6 months from date of application) in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, Biology, Microbiology, or related fields.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Position Title Biology Adjunct Faculty Lecture & Lab (EVENING COURSES - General, Human Anatomy & Physiology, Microbiology, and Plant Studies, General zoology, Genetics, Environmental biology, Hydroponics, and Medicinal plants) - Fall 2024 Campus Cranford, Elizabeth, Plainfield Department Biology Full-time, Part-time, Adjunct Adjunct Exempt or Non-Exempt Exempt Regular,Temporary, or Grant Regular General Description.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Bachelors Degree in Biochemistry, Cell Biology, Microbiology, Chemistry, Engineering or related areas. Conduct weekly meetings with Contract Test Labs (CTL) to provide testing forecast, generate sample submission, provide shipping details to CMO, tract testing status and be point of contact for any test status question in collaboration with ERMs. Work cross functionally to provide single point of contact for CTL sample management to internal teams and external manufacturing partners, as needed.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts IQ/OQ/PQ/UAT , Summary Reports, Trace Matrices, SOPs.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Performs Study Director functions as outlined by FDA Good Laboratory Practices (21 CFR Part 58) for GLP Studies, as well as serves as a technical leader in ensuring proper execution of additional microbiology testing (testing of bioburden, sterility, endotoxin, biological indicators, etc.
TemporaryExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Position Summary:The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client's Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review, and system reporting.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Our client, a leading Pharmaceutical company is hiring a MES Validation Specialist. The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist is integral to our Cell Therapy Above-site organization, providing essential support for our cGMP Document Control operations.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance.
Full-timeExpandApply NowActive JobUpdated Today
microbiology cgmp jobs in Rahway, NJ
FEATURED BLOG POSTS
Resume Job Description Samples - 8 Tips to Follow
When looking for a job, your resume becomes a crucial element. From making a great first impression to showcasing all your achievements and potential, your resume has to portray your professional story in minutes.
Internship Cover Letter Tips with Examples
Until now, college has been about learning, absorbing, and experiencing. It’s not until you become eligible for an internship that things start getting real—real-world experiences using real-life scenarios. Applying for internships takes time, and there’s no college course on “how to apply for jobs.” (We’d sign up immediately if there was, though!) But here's a spoiler alert: most internships require a cover letter. And while this may seem like a burden, it’s actually a blessing.
5 Practical Ways to Remove Bias from your Hiring Process
Many employers think their hiring process is perfect. However, research shows that the hiring processes are generally impartial and unfair, especially if you are part of certain demographics. Women, people of color, people with disabilities, or even people in lower socioeconomic status are more likely to be subject to implicit bias. As diversity and employer branding become major aspects of business, it is important that employers take the lead to identify and remove bias from the hiring process. So, here are 5 practical ways to get you started.
Tips to Get Your First Job Confidently
Whether you’re a recent graduate or you still have a few exams left, you may be itching to put your polished leather shoes on and join the workforce. After all, your first job is an entryway into the professional life you’d lead for the decades to come.
Tips for a Good Character Reference Letter with Examples
Hiring managers love a resume laden with relevant skills and qualifications. Hard skills specific to the role, like SEO strategy or Java programming languages, are easy to qualify using achievements or facts and figures. But how exactly can they verify personality traits, work ethic, relationship management skills, or curious nature during an interview when they barely know you?
How to Dress on the First Day of Work (Men & Women)
You did it! Out of hundreds of applicants and dozens of people interviewed, you’re the one who got a new job. Congrats! Now comes the question of how to dress on the first day of work.
Why College Students Should Work While in College?
College is a special part of our lives. It’s a time when we prepare for our dream job while creating some of the most memorable moments in life. That said, college life can also be stressful. Not only do we have to spend long hours studying, writing and researching, but we also have to deal with increased tuition fees and living expenses.