Director, Vaccines Drug Substance Commercialization - Upstream

MSD•Upper Gwynedd Township, PA

1d•$173,200 - $272,600•Onsite

About The Position

As part of the Manufacturing Division’s Vaccines Drug Substance Commercialization (VDSC) organization, the Upstream department provides technical process leadership and laboratory capabilities for late-stage pipeline and post-market commercial manufacturing of vaccine drug substance upstream processes. VDSC supports process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, regulatory submissions, and second-generation process development. Under the scientific and administrative direction of the Executive Director, VDSC, the Director leads a team of approximately 30 scientists and engineers and works closely with internal and external stakeholders. The Director shapes commercialization strategies for late-stage pipeline products and supports post-market commercial manufacturing commitments. The role serves as the senior technical authority for upstream vaccine process development and commercialization. It provides scientific and operational leadership across process development, scale-up, process control, validation, technology transfer, regulatory alignment, lifecycle management, resource and budget management, talent development, performance management, succession planning, and environmental, health, and safety compliance. The position directs development across multiple platforms and scales, including high-throughput microbioreactors, laboratory-scale stainless-steel and single-use systems, pilot-scale equipment, and commercial manufacturing assets. The primary location is West Point, Pennsylvania. Domestic relocation is available. Travel requirements are 10%. Flexible work arrangements are listed as not applicable, and the shift is not indicated. The role is regular employment. Visa sponsorship is not available.

Requirements

Ph.D. or Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, Biochemistry, or a related field.
At least 10 years of experience leading end-to-end vaccine and/or biologic CMC process development, with emphasis on late-stage projects, regulatory filings, and approvals.
At least 5 years of experience leading CMC projects and directing transversal or functional process development teams.
Proven track record managing large, laboratory-based process development and technology transfer teams.
Deep subject matter expertise in biologics and/or vaccine processing for large molecules, with the ability to independently direct all stages of cell culture and fermentation process commercialization.
Proven experience authoring critical CMC technical documentation, including PPQ, risk assessments, control strategies, comparability reports, and regulatory filings.
Exceptional interpersonal, communication, and matrix-leadership skills.
Ability to mentor staff, foster a high-performance culture, and deliver on tight timelines.
Skills listed: analytical thinking, clinical manufacturing, driving continuous improvement, employee development, GMP, manufacturing equipment, people leadership, pharmaceutical process development, process characterization, process development, process validation, resource management, results orientation, strategic planning, technical leadership, upstream process development, and vaccine manufacturing.

Nice To Haves

Hands-on experience with both fermentation and cell culture, including intensified inoculum, fed-batch, and perfusion process development.
Experience with stainless-steel systems, high-throughput microbioreactors, and advanced in situ analytics for real-time process monitoring.
Experience with predictive modeling and data science, such as Metabolic Flux Analysis, omics, and machine learning, and integrating Process Analytical Technology.
Strong background in mathematical scaling, Computational Fluid Dynamics, Quality by Design, and Lean Six Sigma principles.
Experience providing direct GMP manufacturing support, including batch record reviews and operational oversight.
Direct experience supporting and writing international regulatory filings (IND, MAA, BLA) and interacting with global health authorities, including FDA, EMA, PMDA/JNDA, and TGA.
Demonstrated experience representing the organization at external conferences to influence industry standards.

Responsibilities

Serve as the senior technical authority for upstream vaccine process development and commercialization.
Provide technical direction across mammalian cell culture, live-virus vaccines, microbial fermentation, media and feed strategy, bioreactor engineering, process intensification, scale-up, process characterization, technology transfer, validation, and lifecycle management.
Drive process control and validation strategies for robust drug substance processes at internal and external GMP manufacturing sites, aligned with regulatory expectations and lifecycle plans.
Direct process development and scale-up across varied platforms and equipment, and ensure scale-down models are representative and scientifically justified.
Align and prioritize departmental technical, scientific, and business goals with enterprise priorities and evolving pipeline needs.
Manage team resources, capital and consumable budgets, headcount projections, and financial targets.
Provide expert technical guidance across vaccine upstream process development and commercialization for large-molecule products.
Identify, coach, and develop talent while leveraging internal and external networks.
Evaluate team performance through formal appraisal processes and provide development support.
Establish succession plans and champion career advancement for high-potential talent.
Champion safety and EHS compliance through role modeling, safe-work practices, training, and Gemba walks.