Associate Principal Scientist, Vaccine Drug Product Commercialization

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Associate Principal Scientist, Vaccine Sterile Drug Product Commercialization 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 Associate Principal Scientist to advance and commercialize our biologics pipeline program. This role will focus on driving excellence in process characterization, scale-up, transfer, and process validation activities. Join us to make a significant impact on the commercialization of innovative health solutions.

Requirements

B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; OR Master’s degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience
Experience with drug product process development, optimization, and/or process characterization of vaccine modalities such as conjugates, LVV, VLP, subunit, adjuvants
Working understanding of analytical methods to characterize vaccines
Understanding of current Good Manufacturing Practices (cGMPs) for manufacturing sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations
Understanding of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
Experience with at-scale vaccine drug product manufacturing and fill-finish operations
Technical expertise in sterile drug product fill-finish related manufacturing processes for large molecules, including laboratory and/or 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, with the ability to effectively articulate understanding of process science to drive decision-making, impact assessments, and design of studies in a multi-disciplinary team environment
Experience in drug product fill-finish process optimization, scale-up, and technology transfer of sterile products to pilot/commercial scales

Nice To Haves

Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale
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 Application

Responsibilities

Lead and/or serve on cross-functional Vaccine drug product (DP) working groups to support early and late pipeline programs.
Partner with early development vaccine program teams to ensure that commercial product definition and process definitions align with manufacturing capabilities and robustness objectives.
Lead 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.
Drive strategic initiatives (technical and/or business process related) with partner groups to enable more efficient and rapid commercialization of innovative products.
Provide mentorship, technical oversight, and strategic guidance to employees, using advanced experience to guide others in addressing non-routine and/or difficult issues.
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 validate platform engineering and scientific models for sterile product and process commercialization.
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, innovation, learning, empowerment, diversity, and inclusion.