Principal Scientist, Vaccine Drug Product Commercialization Full-time NEW

Principal Scientist – Vaccine Drug Product Commercialization

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. As part of our 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. We are seeking an experienced Principal Scientist to support commercial vaccine programs/sites, commercialize vaccine pipeline, and support commercial vaccine programs.

Responsibilities

• Execute and provide oversight to drug product and process design, development, characterization, technology transfer, and robust commercial validation
• Lead and/or serve on cross-functional 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
• Lead and support risk assessments, root-cause investigations, and CAPA implementations
• 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 gained on scientific/technical issues to guide others to address non-routine and/or difficult issues
• 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 introduction, and process validation at commercial sites
• Ensure fit-for-purpose scale-down models are developed and employed, establishing and validating 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, including the classification of process parameters, performance parameters, operating ranges, in-process controls
• Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies
• Influence CMC regulatory strategy and be accountable for DP CMC sections of filing, reviewing regulatory strategy and filing readiness, and supporting preparations for agency meetings
• Author and review regulatory submissions
• Drive continuous and phase-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

Qualifications

Required

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
• Master's degree in Chemical engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or 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 vaccine modalities (such as Subunit/VLPs/LVVs/Adjuvants)
• Theoretical understanding and expertise in scale-down model development for one or multiple unit drug product unit operations such as freeze/thaw, mixing, filtration, lyophilization, filling
• Technical expertise in sterile drug product fill/finish, packaging, shipping related manufacturing processes for large molecules (including laboratory and/or fundamental models for key unit operations)
• Understanding of product interactions with contact surfaces, filter membrane, primary containers
• Experience leading and supporting risk assessments, root-cause investigations, and CAPA implementations
• Experience with tech transfer/commercialization (PPQ/Launch)/at-scale commercialization for sterile injectable drug product manufacturing and fill finish operations
• Knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
• Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations
• Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment

Preferred

• Familiarity with our company's vaccine manufacturing network
• Working knowledge in analytical methods and product attributes for vaccine and large biomolecules
• 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

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

Required Skills: Accountability, Biochemistry, Biologics License Application (BLA), Biomedical Engineering, Biopharmaceuticals, Biopharmaceutics, Clinical Manufacturing, Commercialization, Creativity, Cross-Functional Teamwork, Data Analysis, Decision Making, Downstream Processing, Driving Continuous Improvement, Fill and Finish, Immunochemistry, Machine Learning (ML), Manufacturing Processes, Manufacturing Scale-Up, Mentorship, Microbiology, Multivariate Data Analysis, Platform Engineering, Process Characterization

Preferred Skills