- Merck (Rahway, NJ)
- …Skills:** Accountability, Accountability, Adaptability, Automated Manufacturing Systems, cGMP Guidelines, Communication, Cross-Functional Teamwork, Electronic Batch ... Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Management Process, Oral Communications, Personal Initiative, Pharmaceutical Sciences, Pharmacology, Pilot Plant Operations, Process Engineering, Process Optimization, Product… more
- Bristol Myers Squibb (Summit, NJ)
- …in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the ... Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. The candidate may also support data verification and GMP documentation review as needed. **Duties/Responsibilities** + Perform routine testing of in-process, final product, and… more
- Bristol Myers Squibb (Summit, NJ)
- …and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. + Demonstrated technical writing skills. + High problem-solving ... ability/mentality, technically adept and logical. + Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. + Ability to work in a fast-paced team environment, meet deadlines, and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …intermediate and critical quality attributes, statistics, risk assessment approaches, and cGMP principles. + Experienced in building the CMC dossier for regulatory ... submissions within the development section as an author/reviewer. Basic knowledge of regulatory requirements. + Demonstrated problem-solving and troubleshooting skills. + Strong capabilities in experimental design and execution. + Ability to work… more
- Cardinal Health (East Rutherford, NJ)
- …sites as needed (manufacturing products, quality control, radiation safety program, cGMP program, Environmental Health and Safety (EH&S), etc.) + Supports continuous ... improvement initiatives with quality and regulatory, customer service, culture, and financials + Supports the training team as needed + Acts as technical expert + Conducts onboarding training for new hires + Trains in all products for both Quality Control and… more
- Actalent (Princeton, NJ)
- …transfer activities. + Familiarity with FDA, EMEA, ICH, USP, GMP guidelines, and cGMP regulations related to QC labs and cell-based product manufacturing. + Proven ... ability to support lab investigations, deviations, CAPAs, and change controls. + Knowledge of Gene/Cell therapy products, particularly in clinical production. Work Environment This role is based in a growing CDMO specializing in Cell/Gene Therapy at a brand… more
- Actalent (Cranbury, NJ)
- …equipment in the manufacturing facility. + Produce pharmaceutical products according to cGMP standards. + Adhere to Good Documentation Practices. + Coordinate with ... the Quality Assurance Department for line clearance after cleaning. + Collaborate with the Engineering Department or Production Supervisor for equipment/facility breakdowns. + Serve as a trainer to new employees and operators from other processing equipment. +… more
- Bristol Myers Squibb (Summit, NJ)
- …to ensure compliance with applicable local, state, federal regulations (eg, OSHA, EPA, ISO, cGMP ). + Serve as the site lead for EHS data management systems, ensuring ... accuracy and timely reporting of key metrics and performance indicators. + Analyze S&OH performance data to identify trends, create dashboards, and present actionable insights to leadership. + Develop and deliver clear and impactful PowerPoint presentations… more
- System One (Pennington, NJ)
- …Support both Upstream and Downstream manufacturing operations in a cGMP -compliant environment. This role provides hands-on experience throughout the biologics ... production process - from cell culture to protein purification. REQUIREMENTS + High School Diploma or Associate's Degree with 1-5 years of relevant GMP experience OR + Bachelor's Degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …the CMMS, facilities and equipment under strict compliance to OSHA, GDP, GLP, cGMP , federal, state and local regulations. **EDUCATION REQUIREMENTS** **:** + Two year ... Associate Degree in Science related to Pharmaceutical Development plus specialized (mechanical) training related to pharmaceutical processing equipment . + Proficiency in the use of computer programs/systems is essential. PD Mechanic as must maintain their… more
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