- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development ( PD )/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, ... is a leading privately-owned biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders,… more
- University of Southern California (Los Angeles, CA)
- cGMP Process Development ( PD ) Specialized Laboratory TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA ... cell and gene therapies and other biological products for internal/external users. The cGMP Process Development ( PD ) Specialized Lab Technician at the… more
- University of Southern California (Los Angeles, CA)
- cGMP Process Development ( PD ) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP - ... cell and gene therapies and other biological products for internal/external users. The Process Development ( PD ) Specialist is responsible for developing… more
- University of Colorado (Aurora, CO)
- …and HPLC. + Draft and edit Batch Records, Bill of Materials, SOP, Forms for Process Development and cGMP manufacturing documentation. + Document Process ... edit Batch Records, Bill of Materials, SOP, Forms for Process Development and cGMP manufacturing...all cross functional activities including but not limited to Process Development ( PD ) and … more
- University of Colorado (Aurora, CO)
- …chromatography and plate-based assays. o Chemical and Biological Engineering. o Biologics Process Development . o cGMP manufacturing.Applicants must meet ... Development & Manufacturing Supervisor - 37107 University Staff Supervise process development and manufacturing operations for biologics-based therapeutics.… more
- University of Colorado (Aurora, CO)
- …+ Five plus (5+) years of protein expression and purification process development . + At least one year of cGMP manufacturing experience. + Experience ... + Scale-up of multiple biologics manufacturing processes for the cGMP suites. + Capital, facility, and equipment upgrades and...all cross functional activities including but not limited to Process Development ( PD ) and … more
- Fujifilm (College Station, TX)
- …they are assigned + The ability to apply knowledge in support of process development + Knowledge and understanding of cGMP . + Practical lab skills. + An ... **Position Overview** **_Summary_** **:** The Assistant Scientist - Process Development is an entry level...customer programs. + Independent operation of instrumentation in the PD laboratories. + Assist in conducting, data plotting and… more
- Catalent Pharma Solutions (Baltimore, MD)
- …different departments to make sure the process is successfully transferred from PD to cGMP manufacturing + Plan, develop, organize, and implement policies, ... **Job Title:** Sr. Manager Upstream Process Development **City:** Baltimore **State** :...: + Lead the client projects starting from the development and optimization toward cGMP manufacturing for… more
- Danaher Corporation (Westborough, MA)
- …for Cytiva is responsible for providing technical leadership to the Fast Trak Process Development Services (PDS) group by providing technical and scientific ... support for the execution of downstream PD and scale-up process for various biologics...modalities. This position is part of the Fast Trak Process Development Services located in Westborough, MA… more
- Catalent Pharma Solutions (San Diego, CA)
- …leader to join us as Director , Product Development . The Director , Product Development ( PD ) is responsible for providing operational, scientific ... **Title: Director Product Development ** **About Catalent San...problem statements for small molecule and peptide therapeutics. The Director will lead the PD team and… more
- Amgen (Thousand Oaks, CA)
- …join our Drug Substance Technologies - Synthetics (DSTS) group. Amgen's DSTS group within Process Development ( PD ) is responsible for the invention, ... to accelerate pharmaceutical development and to improve sustainability and process efficiency + Support cGMP manufacturing and technology transfer to… more
- Amgen (Holly Springs, NC)
- …of a cross-functional team (ie, QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD ( Process Development ), Regulatory, etc.) in completing production ... a regulated industry such as biotechnology or pharmaceutical + Basic understanding and process experience in a cGMP manufacturing facility + Basic knowledge of… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver ... Manufacturing facilities. + Demonstrates knowledge of mechanical systems, utilities & process equipment required to operate and maintain facilities associated with… more
- ThermoFisher Scientific (Plainville, MA)
- …, a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital ... manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager… more
- Amgen (New Albany, OH)
- …and Validation. + Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams. ... **Basic Qualifications:** High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience Or Associate's + 2 years… more
- Novo Nordisk (Clayton, NC)
- …team designated to provide maintenance & mechanical, & technical support for the API process tracks & operations. Lead & support problem solving & RCA to resolve ... with respect equipment, performance, longevity, efficiency, & reliability. Partner with process track engineers to improve & optimize equipment maintenance plans.… more
- Amgen (New Albany, OH)
- …in a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production ... + Evaluate and approve reports and protocols. + Ensure cGMP and CFR compliance of operating areas. + Revise,...+ Revise, update, and review procedures + Manage the development and revision of SOPs. + Evaluate current operating… more
