- cGMP Consulting (Chicago, IL)
- About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with ... meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Our main client locations… more
- SOFIE (Miami Lakes, FL)
- …by adhering to SOFIE's quality management system and maintain a state of cGMP control at the site. Ensure aseptic operations follow internal procedures (gowning, ... the ability to address chemical or radioactive spills and reporting. Complete cGMP documents as required and assist site and corporate Quality Assurance including,… more
- 3key Consulting, Inc. (Thousand Oaks, CA)
- …document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at our client facilities in Thousand ... Support, Reliability, asset management) Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes,… more
- Merrimack Manufacturing (Manchester, NH)
- …to increase the maturity of our operation under current Good Manufacturing Practice ( cGMP ) conditions. The Director of Engineering is expected to set the example of ... are expected to demonstrate expertise and technical leadership in cGMP compliance and be able to make decisions based...in mechanical engineering with 10-15 years' experience in a cGMP environment or equivalent Minimum Eight (8) years leadership… more
- Meissner Filtration Products, Inc. (Camarillo, CA)
- …safety, reliability, throughput, and maintainability in Class 7 cleanroom, cGMP environments; operates with strong platform-agnostic capability; delegates work to ... actions; document lessons learned for reuse. Validation/documentation: support formal cGMP validation (IQ/OQ/PQ) led by Process Engineering, Manufacturing Engineering,… more
- Rigel Pharmaceuticals Inc. (San Francisco, CA)
- …ensures timely batch record review, product disposition, and adherence to cGMP requirements. It also supports internal readiness for manufacturing campaigns, ... and testing activities at contract organizations are performed in compliance with cGMP standards. Lead Rigel Quality Event program to ensure effective investigation… more
- New River Community College (Richmond, VA)
- …that advance access to medicines. Develop new partnership opportunities for M4ALL's cGMP kilo facility in partnership with Business Operations. Review and approve ... production operations at our Central R&D (Richmond, VA) and cGMP Kilo Facility (Chesterfield, VA) sites. The team ensures...advancement of API process innovations from Process R&D to cGMP production in partnership with VCU Occupational Health &… more
- Cytokinetics (San Francisco, CA)
- …brings expertise in Lean Six Sigma, pharmaceutical manufacturing processes (including cGMP ), and the unique challenges of managing a global external manufacturing ... plans.* Lead joint improvement initiatives with external partners while ensuring cGMP and regulatory compliance.* Build strong relationships and foster a culture… more
- SOFIE (Totowa, NJ)
- …for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is expected that the development of these protocols ... and maintenance instructions, and procedure manuals required. Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification… more
- Dendreon, Inc. (Seattle, WA)
- …including method protocols, development reports, and transfer reports. Apply knowledge of cGMP principles in laboratory practices. Serve as a technical resource on ... of significant practical experience in molecular biology. Working knowledge of cGMP requirements. Experience with cell culture techniques, especially iPSC, is a… more
