- Cardinal Health (Trenton, NJ)
- …pharmaceutical products, ensuring compliance with current Good Manufacturing Practices ( cGMP ) and relevant regulatory guidelines. This role demands a strong ... oversee the stability program and related studies, ensuring alignment with cGMP requirements and industry best practices. + **Repackaged Product Stability:** Manage… more
- Bristol Myers Squibb (Summit, NJ)
- …product Value Stream outputs according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work ... and local laws. + Drive compliance with current Good Manufacturing Procedures ( cGMP ), USP, EU and other global regulatory requirements. + Drive completion, adherence… more
- Hovione (East Windsor, NJ)
- …with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the early designing phases, guarantee ... that cGMP and HSE requirements and adequate Engineering solutions are...review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated -… more
- System One (Cranbury, NJ)
- …Cleaned and maintained compression/press equipment per SOP + Ensured compliance with cGMP , SOPs, and FDA regulations + Completed accurate batch records and ... in the production of solid oral dosage forms in a cGMP -regulated pharmaceutical environment. This role involves equipment setup, in-process testing, documentation,… more
- J&J Family of Companies (Raritan, NJ)
- …performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the ... commercial operation in a controlled current Good Manufacturing Practice ( cGMP ) cleanroom environment. *Independently execute manufacturing or manufacturing-support processes… more
- Catalent Pharma Solutions (Princeton, NJ)
- …our European Center of Excellence for cell therapy in Gosselies, Belgium. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and ... Procedures in a controlled Clean Room environment and following cGMP guidelines and FDA standards and safety regulations. The...standards. + Executes and completes Batch Production Records under cGMP , and documents in detail using SOPs, FORMS and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and other related documents (ie change orders). + Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and ... are focused on continuous improvements. + Participates in assigned training including CGMP and safety training. + Authors and reviews procedural documents. + Manages… more
- Astrix Technology (New Brunswick, NJ)
- …supports late-stage clinical and commercial products by performing and reviewing cGMP -compliant lab tests, requiring strong protein chemistry skills and analytical ... release, raw material, and stability programs. + Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines. + Participate in… more
- J&J Family of Companies (Raritan, NJ)
- …the autologous CAR-T products in a controlled current Good Manufacturing Practice ( cGMP ) cleanroom environment. **You will be responsible for:** * Perform process ... time in a manner consistent with the safety policies, quality systems and cGMP requirements. * Execute production activities common to cell culture in shake flasks… more
- Hovione (East Windsor, NJ)
- …pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. ... costumer requirements. - Fulfill all applicable current Good Manufacturing Practices ( cGMP ) and Health Safety and Environment (HSE) regulations and relevant… more