Associate Principal Scientist, Engineering

Associate Principal Scientist, Biologics, Sterile Drug Product Commercialization

As part of Our Company’s 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.

Responsible for leading late‑stage commercialization activities, including process scale‑up, technology transfer, process validation, regulatory submissions, and supporting significant manufacturing investigations. The role drives excellence in process characterization, scale‑up, transfer, and validation, ensuring that commercialization programs meet science, quality, reliability, schedule, and cost requirements.

• Lead or serve on cross‑functional biologics drug product (DP) working groups, managing DP activities through filing and Process Performance Qualification (PPQ), including registration stability studies, process characterization plans, tech transfer controls, PPQ readiness, PAI readiness, approval, launch, and post‑launch support.
• Ensure commercialization programs meet science, quality, reliability, schedule, and cost standards.
• Drive strategic initiatives—technical or business process related—to enable more efficient and rapid commercialization.
• Provide mentorship, technical oversight, and strategic guidance to employees.
• Develop a process and product development plan, influencing decisions related to primary packaging and combination product design.
• Design and execute DP development and commercialization studies, new product introductions, and process validation at commercial sites.
• Develop and validate fit‑for‑purpose scale‑down models and platform engineering and scientific models for sterile product and process commercialization.
• Innovate 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 and author DP CMC sections of filings; review regulatory strategy and filing readiness, support agency meetings, and author regulatory submissions.
• Drive continuous and phased 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.

Requires up to 25% travel; must be able to travel for this position.

• B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience.
• Master’s degree in the same fields with 8 years of relevant experience.
• Ph.D. in the same fields with 4 years of relevant experience.

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

• Experience in biologics drug product fill‑finish process optimization, scale‑up, and technology transfer of sterile products to pilot/commercial sites.
• 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.
• Working knowledge of current Good Manufacturing Practices (cGMPs) and ICH Quality norms for sterile dosage forms.
• Statistical methods for DOE design,…