Job Description The Global Operations and Sourcing (GOS) lead is responsible for owning supplier relationships... molecule drug substance (DS) and drug product (DP) modality, Biologics DS and DP modality, Vaccines DS and DP modality...
, development, characterization, technology transfer, and robust commercial validation. Serve on cross functional drug product (DP...) working group and supports intravitreal DP activities through filing and Process Performance Qualification (PPQ), site...
development. Manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability... plan. Responsible for the design and execution of DP development and commercialization studies, new product introduction...
network. Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development... Must Have Skill Sets: 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment. 5+ years in roles...
, including advanced knowledge of key unit operations in pre-clinical/clinical manufacture Familiar with vaccine adjuvant... regulatory filings for sterile dosage forms (adjuvants and/or DP) Experience responding to regulatory questions related to drug...
expertise in unit operations commonly used to manufacture vaccine drug products (lyophilization, sterile filtration, vial... for sterile dosage forms (adjuvants and/or DP) Experience responding to regulatory questions related to drug products...
understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection... product manufacturing operations Qualifications: Master's Degree in life sciences or engineering 2 years of related...
understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection... product manufacturing operations Qualifications: Master's Degree in life sciences or engineering 2 years of related...