Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

Principal Scientist, Biologics, Sterile Drug Product Commercialization

As part of our company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics. It is the division’s leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.

The group establishes the science, engineering and knowledge required for today’s innovative and accelerated commercialization of biologics and combination products. We are seeking an experienced Principal Scientist to advance and commercialize biologics pipeline programs.

• Execute and provide oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation.
• Lead and/or serve on cross-functional biologics drug product working groups and manage drug product activities through filing, Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, technology transfer control strategy, PPQ readiness, Pre-Approval Inspection (PAI) readiness, approval, launch and post-launch support.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Drive strategic initiatives (technical and/or business process related) to enable more efficient and rapid commercialization of innovative products.
• Provide mentorship, technical oversight and strategic guidance to employees.
• Use advanced experience to guide others to address non-routine and/or difficult issues.
• Develop a product and process development plan; influence decisions related to primary packaging and combination product design.
• Design and execute drug product development and commercialization studies, new product introduction and process validation at commercial sites.
• Ensure fit-for-purpose scale-down models are developed and employed.
• Establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Innovate and drive best practices for commercial site technology transfer, facility fit and development of the drug product control strategy, including classification of process parameters, performance parameters, operating ranges and in-process controls.
• Drive and influence process demonstration and qualification (PPQ) and shelf‑life strategies.
• Influence CMC regulatory strategy and be accountable for drug product CMC sections of filing; review regulatory strategy and filing readiness and support preparations for agency meetings; author and review regulatory submissions.
• Drive continuous and phase-appropriate process optimization toward standardized platforms for liquid, lyophilized, and combination product presentations.
• Travel up to 25% as required.

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience.
• M.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience.
• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience.

• Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs and/or fusion proteins).
• Experience with at-scale biologics drug product manufacturing and fill-finish operations.
• Experience with late-stage commercialization of biologics programs.
• Technical expertise in sterile drug product fill-finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
• Experience with technology…