Principal Scientist, Sterile Drug Product Commercialization

Full-time - Senior

Onsite - West Point, PA

Chemical Manufacturing

About the position

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 vaccines, biologics, and sterile pharmaceutical products. 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 novel vaccines, biologics, and pharmaceutical products and combination products. We are seeking an experienced Principal Scientist to advance and commercialize a live virus vaccine (LVV) pipeline program. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process scale up, transfer and process validation activities at the manufacturing site. The role involves executing and providing oversight to LVV product and process design, development, characterization, technology transfer, and robust commercial validation. The Principal Scientist will serve on cross-functional drug product working groups and support LVV lyophilized drug product activities through filing and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection (PAI) readiness, approval, launch, and post-launch support. The successful candidate will ensure that commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. They will provide mentorship, technical oversight, and strategic guidance with respect to LVV process optimization, using advanced experience gained on scientific and technical issues to guide others in addressing complex technical challenges. The Principal Scientist will develop a process and product development plan, influence decisions related to primary packaging and combination product design, and innovate best practices for commercial site tech transfer, facility fit, and development of the drug product control strategy. This includes the classification of process parameters, performance parameters, operating ranges, and in-process controls. The role also involves driving and influencing process demonstration and qualification (PPQ) and shelf-life strategies, influencing CMC regulatory strategy, and authoring DP CMC sections of filing. The Principal Scientist will create best practices in LVV process scale down, parameter finding, site characterization, and transfer, while establishing a culture of high performance, innovation, and learning.

Responsibilities

• Execute and provide oversight to LVV product and process design, development, characterization, technology transfer, and robust commercial validation.
• Serve on cross-functional drug product working groups and support LVV lyophilized drug product activities through filing and Process Performance Qualification (PPQ).
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Provide mentorship, technical oversight, and strategic guidance with respect to LVV process optimization.
• Develop a process and product development plan and influence decisions related to primary packaging and combination product design.
• Innovate and drive best practices for commercial site tech transfer, facility fit, and development of the drug product control strategy.
• Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy and author DP CMC sections of filing.
• Create best practices in LVV process scale down, parameter finding, site characterization, and transfer.
• Establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
• Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
• Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience.
• Comprehensive knowledge and hands-on experience in live virus vaccines.
• Working knowledge in cell-based assays for live-virus vaccines such as reporter gene assays, TCID50, plaque, and infectivity.
• Experience with the manufacturing of sterile drug products (vaccines, biologics) at the pilot or commercial scale.
• Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations.
• Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules.
• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Excellent oral and written communication skills.

Nice-to-haves

• Experience in LVV drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
• Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles.
• Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.
• Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
• Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.