- Astrix Technology (New Brunswick, NJ)
- …late-stage clinical and commercial small molecule and biosimilar products within cGMP -compliant laboratories. This person will effectively perform and troubleshoot a ... release, raw material, and stability programs. + Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines. + Participate in… more
- Bristol Myers Squibb (Warren, NJ)
- …deepen client relationships. **Specific Knowledge, Skills, Abilities:** + Knowledge of cGMP , GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems ... and experience in laboratory and manufacturing operations. + Knowledge of cGMP in the pharmaceutical industry. + Excellent computer skills including knowledge… more
- Bristol Myers Squibb (Summit, NJ)
- …per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing ... and aseptic processing or lab technique + General understanding of cGMP /FDA regulated industry + Familiarity with Lean Manufacturing initiatives + Basic… more
- Bristol Myers Squibb (Summit, NJ)
- …components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing ... purification, and aseptic processing or lab technique + Knowledge of cGMP /FDA regulated industry + Basic mathematical skills + General understanding of… more
- Bristol Myers Squibb (Summit, NJ)
- …both internal and regulatory audits. **Knowledge & Skills:** + Knowledge of cGMP , GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation ... Experience working in a commercial environment preferred. + Knowledge of cGMP in the pharmaceutical industry. **Working Conditions:** + Occasional stooping, bending,… more
- Sokol Materials & Services (Skillman, NJ)
- …should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral ... cellular immunology and/or vector manufacturing a plus. + Experience with cGMP , ICH guidelines, PPQ (process validation), control strategy development, and working… more
- System One (Cranbury, NJ)
- …utilities qualifications. All activities will be performed in compliance with cGMP , FDA, and other applicable regulatory standards. Responsibilities: + Perform ... and utility qualification and requalification activities to ensure compliance with cGMP and quality requirements. + Prepare and execute IQ/OQ/PQ protocols for… more
- Sokol Materials & Services (Skillman, NJ)
- …of new biopharmaceutical manufacturing facilities. + Basic knowledge of cGMP 's and multi-national biopharmaceutical/cell therapy regulations. + Basic knowledge of ... strategies, managing supply forecasts, and driving process improvements within cGMP operations. Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) About the Company Join… more
- Actalent (Cranbury, NJ)
- …activities, as well as requalification processes to ensure compliance with cGMP and quality requirements. The position requires assisting in the preparation ... validation + Knowledge of solid dosage manufacturing + Understanding of cGMP requirements + Facility qualification expertise Additional Skills & Qualifications +… more
- Actalent (Fairfield, NJ)
- …and Qualifications: + Must have a strong working knowledge of basic lab techniques and cGMP standards to ensure the maintenance of the cGMP standard of quality. ... + Experience in product and formula development and product evaluation. + Must possess strong knowledge of costing of ingredients and technology + Ability to read and interpret documents such as safety rules, operating and maintenance work instructions,… more