Role
Senior Scientist leading sterile drug product process development for biologics pipeline and commercial programs, focusing on establishing scalable, robust manufacturing processes.
Responsibilities
- design and execute process studies, develop transfer strategies to manufacturing sites, author regulatory documentation, and support process validation and lifecycle management; optimize processes for cost, robustness, and efficiency; and contribute to regulatory filings.
Qualifications
- B.S. in Chemical/Biochemical Engineering, Microbiology, or related with 6+ years (or MS with 4+ years, PhD with no experience); strong experience in biologics process development, scale-up, and technology transfer; proficiency with DOE, process validation, and regulatory document authoring.
Preferred
- experience with sterile biologic manufacturing, process optimization, cGMP compliance, and QbD principles; project management skills.
High-Value
- biologics (large molecules), sterile dosage forms, late-stage or commercial manufacturing, CMC regulatory support, and process validation.
Collaboration
cross-functional support within manufacturing division, with travel up to 25%.
Work setup
based in West Point, PA, with some travel; support for European sites.
#J-18808-LjbffrSr. Scientist, Engineering in pa at Unknown Company
This position is listed as full time and onsite.