between development and GMP manufacturing. Manage day-to-day CDMO relationships and performance, including timelines, deviations, batch... and stochastic conjugation approaches. ADC development and GMP production, including the process, analytical, and containment...
to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold... role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note...
, Architect/Engineer, BIM team, construction team, equipment vendors, and GMPconsultants to: Process Equipment Layout... in design reviews, constructability reviews, and GMP-related discussions. Support development of documentation...
compliance with regulatory requirements and industry standards such as FDA, cGMP, GAMP, and EU GMP Annex 11. Oversee and conduct..., and documentation standards. Manage relationships with external vendors and consultants to support validation projects and ensure...
complete and competitive bids for various contract types, including Lump Sum, GMP, and Cost Plus, while maintaining consistency... gaps or overlaps. Champion Collaboration & Communication: Serve as a liaison among subcontractors, designers, consultants...
complete and competitive bids for various contract types, including Lump Sum, GMP, and Cost Plus, while maintaining consistency... gaps or overlaps. Champion Collaboration & Communication: Serve as a liaison among subcontractors, designers, consultants...
, contractors, and external consultants. Ensure compliance with applicable codes and standards (NFPA, ASME, OSHA, local regulations... licensure a plus Experience in pharmaceutical, healthcare, or regulated manufacturing environments. Familiarity with GMP (Good...
vendors/consultants, ensuring contracts, technical specifications, and deliverables meet requirements. Effectively lead... and standards Direct experience working in regulated environments (GMP, OSHA, EPA) Willingness to travel (30...
. Serve as the primary interface between ownership, architects, consultants, and project teams. Support business development..., and manage project risks and opportunities. Build and maintain strong relationships with owners, architects, consultants...
vendors/consultants, ensuring contracts, technical specifications, and deliverables meet requirements. Effectively lead... and standards Direct experience working in regulated environments (GMP, OSHA, EPA) Willingness to travel (30...