- BioBridge Global (San Antonio, TX)
- …operating procedures (SOPs) and batch records including media and solution preparation; drug substance preparation; and drug product fill operations. ... sterility of cell therapy products from vial thaw to final formulated drug product cryopreservation. Perform tasks in a manner consistent with safety policies,… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …field, or + MS in Chemistry or related field and 5 years of experience evaluating drug product performance and quality, or + BA/BS in Chemistry or related field ... and 10 years of experience evaluating drug product performance and quality. **Additional Desired Preferences** + Must have the capability to plan and conduct… more
- Catalent Pharma Solutions (Kansas City, MO)
- …CMC services for stand-alone and integrated biologics projects. Eg analytical support for drug substance, drug product , and intermediates for both innovator ... fields including managerial roles; + Experience with sterile and blood drug product development, manufacturing and testing is strongly preferred; + Experience… more
- Sanofi Group (Cambridge, MA)
- …+ Responsible for physical and financial flow settings from Raw Material (RM) till Drug Product (DP) or Finished Goods (FG) Manufacturing step with relevant ... manages relationships with external Contract Manufacturing Organizations (CMOs) as suppliers of drug substance, drug products and finished goods for Sanofi… more
- US Tech Solutions (Cambridge, MA)
- …Liquid Chromatography (UHPLC), Capillary Electrophoresis (CE), and Tecan in support of Drug Substance, Drug Product , and Attribute Sciences process ... to pivotal Quality Control teams. + Perform forced degradation studies to support product characterization, understanding of product stability and evaluation of … more
- Fujifilm (Holly Springs, NC)
- …oversees comprehensive cleaning validation program for multi- product manufacturing suites including Drug Substance, Drug Product , and Weigh and Dispense ... production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director collaborates with cross-functional teams to drive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance, drug product , and devices. + Experience in ... requirements for drug development and manufacturing of a range of product modalities. + Comprehensive understanding of the biopharmaceutical industry, R&D, and … more
- Amgen (New Albany, OH)
- …organization, this role serves as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. NPI scope ... may include the implementation of various drug product formats (eg vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including… more
- Lilly (Concord, NC)
- …The Molecule Steward is the subject matter expert for the Concord Site Drug Product manufacturing and will provide local technical leadership and expertise ... as technical subject matter expert for all topics related to drug product manufacturing. + Expected to provide technical direction on deviations, production… more
- Pfizer (Bothell, WA)
- …scientific field. + Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities. + ... physico-chemical characterization efforts for Pfizer's biotherapeutics portfolio, which includes antibody- drug conjugates (ADCs), nucleic acid delivery systems, monoclonal antibodies,… more