- AbbVie (North Chicago, IL)
- … control strategies, comparability studies and extended characterization of biologics . + Collaborate with third party laboratories to ensure CMC timelines ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Biologics Analytical Research & Development ( Biologics ARD) is a global… more
- Boehringer Ingelheim (Athens, GA)
- …impact licensed products and BI licensed manufacturing facilities in the USA (eg Change Control , Deviations, Outlines of Production, claim extensions). + Assure ... and related USDA published guidance in collaboration with manufacturing, quality assurance, quality control , and R&D. + May lead 1-2 people. If leading projects… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Lead or contribute to project workstreams such as risk assessments, control strategy management, continuous improvement, and change management throughout the ... leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're...the care of patients with life-threatening diseases. The Senior Biologics Engineer II (Drug Substance) role is focused on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …investigations, Material Review Board associated investigations, finished product trending, and change control + Fosters and facilitates continuous improvement ... We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …in a GMP environment for biologics manufacturing and a BS or BA, with change control experience a must. + 4+ years of relevant experience and a MS. ... We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster… more
- Catalent Pharma Solutions (Madison, WI)
- …Process Engineer - Manufacturing Sciences & Technology, Upstream** **Summary** Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused ... new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park,… more
- Lilly (Branchburg, NJ)
- …be supporting day to day automation activities, driving appropriate GMP change control /deviation, preparing/adhering project schedules, and programming process ... systems, as applicable. Will be providing technical support for daily biologics manufacturing operations and for the specification, installation, start-up and… more
- Mayo Clinic (Rochester, MN)
- … in the Viral Vector Production Laboratory (VVPL). This Biomanufacturing Specialist Lead will be responsible for managing quality control operations, including ... **Responsibilities** The Biomanufacturing Specialist Lead is the primary process development and/or manufacturing expert supporting the production of regenerative… more
- ThermoFisher Scientific (St. Louis, MO)
- …Specific Information** This position supports the QC Analytical team for our Biologics Division in St. Louis, MO. **How will you make an impact?** ... The Scientist III (QC Lead ) will be responsible for the performance of project...performance of project management for the Client Facing- Quality Control in support of Commercial and Clinical Biopharmaceutical Manufacturing.… more
- ThermoFisher Scientific (St. Louis, MO)
- …Specific Information** This position supports the QC Analytical team for our Biologics Division in St. Louis, MO. **How will you make an impact?** ... The job will be responsible for Quality Control Project Leads Department and will support of Commercial...with both internal and client facing customers, and managing change controls and revision of documents per ICH guidelines… more
- Mayo Clinic (Rochester, MN)
- …resources you need to succeed. **Responsibilities** The Biomanufacturing Specialist Lead is the primary process development and/or manufacturing expert supporting ... environment. Experience in a cGMP environment manufacturing clinical-grade human cells, biologics , biomaterial, or other product intended for human use is preferred.… more
- Catalent Pharma Solutions (Bloomington, IN)
- …Director, Technical Services** **Location: Bloomington, IN** **Position Summary:** Catalent Biologics is a fast-growing business within Catalent Pharma Solutions ... new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park,… more
- Sanofi Group (Framingham, MA)
- …Platform. SC-MSAT department is responsible for product stewardship of all Biologics based Specialty Care products including leading technology transfer and ... in R&D. The function is also responsible for implementing product control strategies, provide technical support to manufacturing sites for significant deviations… more
- Catalent Pharma Solutions (Madison, WI)
- …and Purchase Specifications, and High-Level Risk Assessments (HLRA) + Drafting and execution of change controls and change control action for new technology ... **Senior Supervisor - Engineering** **Summary** Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative… more
- Charles River Laboratories (Memphis, TN)
- …Quality Systems organization, which manages oversite of GMP systems such as deviations, CAPA, Change control , OOSs, and document control . You will support ... team members on pertinent use of QMS (Investigations, CAPA, Change Control , etc) + Audit and support...etc) + Audit and support performance of investigations, CAPAs, Change controls, etc + Lead projects within… more
- Sanofi Group (Framingham, MA)
- …and Global Cell Banking operations as well as the 8 New York Avenue Biologics Facility. In addition, the F&E organization is responsible for our warehouses in ... for all cGMP process and utility systems at Framingham Biologics , maintaining these systems in a validated state of..., maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is… more
- Charles River Laboratories (Memphis, TN)
- …for product disposition + Write minor/major investigations and/or create/generate CAPA and Change Control projects + Take initiative to execute continuous ... Laboratory Equipment Lifecycle, EM Data Trending, and/or Laboratory Compliance (Deviations, CAPAs, Change Controls, etc) + Lead and assist in managing the… more
- AbbVie (North Chicago, IL)
- …pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC Development and Aesthetics R&D functions to provide active ... engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products, including toxins and cosmetic active… more
- Charles River Laboratories (Memphis, TN)
- …CFR Part 11, and GAMP5. + Advanced understanding of the Quality Management System, Change Control , and CAPA **Job Qualifications** + Minimum of BA/BS degree in ... Memphis, TN. The Sr. Engineer will have the experience to be functional lead responsible for Validation (CQV) deliverables for the facility, utilities, systems and… more
- Charles River Laboratories (Memphis, TN)
- …Good Distribution Practice (GDP) and current Good Manufacturing Practice (GMP). + Lead , develop and mentor a Quality Assurance team + Work collaboratively with ... the Biomanufacturing, Quality Systems, Quality Control , Project Management, Facilities, and Supply Chain units to...corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Distribution. + Conducts gap… more