- Hovione (East Windsor, NJ)
- …pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. ... right first time, on time and within budget) and in compliance with cGMP , HSE regulations and internal policies and procedures. - Responsible for the accurately… 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
- 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
- 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)
- …of Cell Therapy products according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work ... Instructions (WIs). Safety: + Takes personal responsibility to work safely and to ensure their WCT members do the same. + Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior. + Operates and maintains… 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