Process Development Associate Scientist, Drug Product Visual Inspection Sciences
Core
Lead the creation of visual inspection defect standards and design characterization studies to support clinical and commercial new product introductions for parenteral drug products.
Role type
Associate Scientist, Process Development (Visual Inspection Sciences)
Builds
Visual inspection defect creation processes and standards for parenteral drug products
Domain
Biopharmaceutical manufacturing (Drug Product)
Required skills
Visual inspection defect creation, GMP compliance, cGMP manufacturing environment knowledge, aseptic processing principles, technical problem solving, protocol design, SOP authoring, project management, cross-functional collaboration
Preferred skills
Advanced degree in engineering/biotech/life sciences, 4+ years drug product process development experience, leadership of multi-functional teams, knowledge of freeze/thaw/filtration/filling/lyophilization/capping processes, ability to communicate complex technical concepts
Technologies
None explicitly listed beyond general manufacturing equipment context
Responsibilities
Lead creation of visual inspection defect standards for NPIs, design and document on-site DP characterization studies, ensure adherence to safety and training policies, build relationships with global network partners, act as single point of contact for defect creations, support continuous improvement of visual inspection programs
Seniority
Associate Scientist (Mid-level IC)
