Associate Principal Scientist, Engineering

Associate Principal Scientist, Biologics, Sterile Drug Product Commercialization

As part of our Manufacturing Division, the Sterile Drug Product Commercialization group provides technical process leadership and laboratory capabilities for late‑stage and commercial drug product processes for biologics and combination products. It is the division's leader in sterile product and process development, responsible for scale‑up, technology transfer, process validation, regulatory submissions, and significant manufacturing investigations, establishing the science, engineering, and knowledge required for accelerated commercialization.

• Lead 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, tech transfer control strategy, PPQ readiness, 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, addressing non‑routine and difficult issues.
• Develop a process and product development plan, influencing decisions on 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; 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 DP control strategy, including classification of process parameters, performance parameters, operating ranges, and in‑process controls.
• Influence CMC regulatory strategy, author and review regulatory submissions, and support preparations for agency meetings.
• Drive continuous and phase‑appropriate process optimization toward standardized platforms for liquid, lyophilized, and combination product presentations.
• Establish and foster a culture of high performance, innovation, empowerment, diversity, and inclusion.

This position may require up to 25% travel. Candidates must be able to travel as required.

• B.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biochemistry, Microbiology, or related field with 10 years of relevant experience.
• Master's degree in a related field with 8 years of relevant experience.
• Ph.D. in a related field with 4 years of relevant experience.

• Experience with drug product process development, optimization, and/or characterization of biologics.
• Experience with at‑scale biologics drug product manufacturing and fill‑finish operations.
• Technical expertise in sterile drug product fill‑finish processes for large molecules, including laboratory and fundamental models for key unit operations.
• Experience with technology transfer and scale‑up of processes to pilot and/or manufacturing scales.
• Excellent oral and written communication skills, and the ability to articulate process science for multidisciplinary teams.

• Experience in biologics drug product fill‑finish process optimization, scale‑up, and technology transfer of sterile products to pilot/commercial stages.
• Operations experience in the manufacturing of potent and sterile drug products at pilot and/or commercial scale.
• Experience with late‑stage commercialization of biologics programs.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including Quality by Design principles.
• Knowledge of current Good Manufacturing Practices (cGMPs) for sterile dosage forms, ICH Quality norms, statistical methods for DOE design, SPC, MVA, and PAT techniques.
• Experience…