- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics Drug Product Development group develops monoclonal antibodies, antibody drug ... conjugates (ADC), and other biologics using state of the art formulation and process...processes, and prepare and defend CMC (Chemistry, Manufacturing and Control ) regulatory content. We are seeking a motivated and… more
- 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
- AbbVie (South San Francisco, CA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are seeking a highly ... motivated, experienced leader to lead a diverse team of pharmaceutical development scientists supporting the development of therapeutic biologics . The candidate… 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 ... **Job Description** **Key Responsibilities:** Senior Director, Global External Manufacturing, Biologics will lead an organization to ensure uninterrupted… 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. (Foster City, CA)
- …in a GMP environment for biologics manufacturing and a BS or BA, with change control experience a must. **(OR)** + 3+ years of relevant experience and a ... 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
- System One (Exton, PA)
- …Science Degree in Life Sciences or related field + Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management ... Title: Quality Control Laboratory Manager Location: Exton, PA Type: Contract...Company is looking for a hands on manager to lead and oversee their QC Lab in operational activities… 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
- 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
- Catalent Pharma Solutions (Bloomington, IN)
- …is strongly preferred. + Extensive knowledge of Quality Assurance and Quality Control . + Proven ability to lead a large, multi-level/multi-shift organization ... Director, Quality Assurance - Formulation and Fill** **Position Summary:** Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on… 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
- Amgen (Holly Springs, NC)
- …Master Data group to support paperless functionality of the labs. + Support Change Control and Validation of Laboratory electronic systems during facility start ... including technical writing and presentation. + Familiar with authoring or owning change control records. + Experience with equipment and method validation,… 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