Principal Scientist, Engineering

Job Description 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 is responsible for establishing 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. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.

• 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 (DP) working groups and manage DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‑Approval Inspection) 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) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
• Provide mentorship, technical oversight and strategic guidance to employees, using advanced experience to address non‑routine and/or difficult issues
• Develop a process and product development plan and influence decisions related to primary packaging and combination product design
• Design and execute DP development and commercialization studies, new product introduction and process validation at commercial sites
• Ensure fit‑for‑purpose scale‑down models are developed and employed, and establish and validate platform engineering and scientific models for sterile product and process commercialization
• Innovate and drive best practices for commercial site tech transfer, facility fit and development of the DP control strategy, classification of process parameters, performance parameters, operating ranges, in‑process controls, and drive and influence process demonstration and qualification (PPQ) and shelf‑life strategies
• Influence CMC regulatory strategy, be accountable for DP CMC sections of filing, review regulatory strategy and filing readiness, and support agency meetings; author and review regulatory submissions
• Drive continuous and phased appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations
• Establish and foster a culture of high performance, out‑of‑the‑box thinking, innovation and learning, empowerment, diversity and inclusion

This position may require travel up to 25 %; must be able to travel for this position.

• B.S. in Chemical Engineering, Biochemical Engineering, Bio‑engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience
• Master’s degree in Chemical Engineering, Biochemical Engineering, Bio‑engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience
• Ph.D. in Chemical Engineering, Biochemical Engineering, Bio‑engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience

• Experience with drug…