- Lilly (Indianapolis, IN)
- …and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant ... and resilience as the site grows to a full scale GMP manufacturing through start up. **Responsibilities** Key Objectives/Deliverables: + Technical Leadership… more
- ThermoFisher Scientific (Allentown, PA)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail ... that are based on sound quality/compliance principles and appropriate GMP Regulations. **A Day in the Life:** + Apply...changes to facilities and equipment. + Review and Approve GMP documents to ensure compliance with all applicable internal… more
- Genentech (Hillsboro, OR)
- …Quality Assurance, Engineering, and other Customers and Suppliers. + You will ensure GMP -compliant validation practices according to PQS, EU GMP Annex 1, and ... a minimum of 8+ years experience in a sterile GMP environment; Masters Degree is preferred. + You have...familiarity with regulatory guidelines (ISO 13408-1, PIC/S, FDA, EU GMP Annex 1) + You have experience planning, executing,… more
- Genentech (Hillsboro, OR)
- …Transfers and Make/Assess/Release activities in a 24x7 Goods Manufacturing Practice ( GMP ) environment. You will be the site's primary technical and compliance ... Manufacturing IT Applications in a 24x7 Good Manufacturing Practice ( GMP ) environment. + Oversee the procurement, advanced development, integration, modification,… more
- Mentor Technical Group (Millbrae, CA)
- …responsible for maintaining, repairing, and troubleshooting equipment and systems in GMP -regulated environments. The ideal candidate will be skilled in multiple ... corrective maintenance on mechanical, electrical, and HVAC systems within regulated ( GMP ) areas. + Troubleshoot systems using electrical and mechanical diagnostic… more
- Sanofi Group (Waltham, MA)
- …for an experienced purification process development professional with experience in GMP manufacturing and technology transfer (TT) to join the GMU Purification ... Ready to get started? **Main Responsibilities** + Have extensive knowledge of GMP manufacturing and technology transfer to manufacturing sites + Make strong… more
- Lilly (Lebanon, IN)
- …the facility and the culture to enable a successful startup into GMP manufacturing operations._ **Main Purpose and Objectives of Position:** The Senior Director ... the necessary systems and business processes required to support GMP operations, and build the plant culture. This will...and resilience as the plant grows to full scale GMP manufacturing through start up. **Key Responsibilities for this… more
- Genentech (Holly Springs, NC)
- …architecture components and Recipe Authoring for drug product manufacturing processes in GMP environment + Co-create MES strategy and roadmap with business partners ... + Accountable for MES Support team in a 24/7 GMP Manufacturing environment + Lead teams/ Provide 24/7 on...Provide 24/7 on call support for Manufacturing Computerized Systems ( GMP ) + Work to identify opportunities to create additional… more
- PCI Pharma Services (Madison, WI)
- …the Facilities, Systems, Utilities and Equipment (FSUE). The incumbent supervises the GMP maintenance staff and will be responsible for execution of the day-to-day ... (FSUE) in an operational state compliant with regulatory requirements for a GMP environment. Responsible for driving the PCI culture through values inclusive of… more
- University of Pennsylvania (Philadelphia, PA)
- …that target the transition of research concepts into robust, compliant, and scalable GMP operations while participating in GMP manufacturing operations. The PDE ... Practices. Demonstrated expertise as an operator and knowledge on GMP cell processing equipment, laboratory techniques, and manufacturing processes required.… more