Director, Vaccines Drug Substance Commercialization - Upstream

Merck•Upper Gwynedd Township, PA

4d•$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 the upstream portion of vaccine drug substance processes. VDSC supports commercialization activities and second-generation process development, including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and regulatory submission authoring. Under the scientific and administrative direction of the Executive Director, VDSC, the Director leads a team of 30 scientists and engineers and works closely with internal and external stakeholders. The role shapes commercialization strategies for late-stage pipeline products and champions post-market commercial manufacturing commitments to deliver vaccines globally. The Director provides senior technical leadership for upstream vaccine process development and commercialization, oversees technical and manufacturing delivery to GMP sites, and directs process development and scale-up across multiple platforms. The role aligns departmental priorities with enterprise goals and manages team resources, capital, and consumable budgets. It also develops talent, evaluates performance, plans succession, and champions safety and EHS compliance.

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 filing, 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 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, including the ability to mentor staff, foster a high-performance culture, and deliver on tight timelines.
Analytical thinking, clinical manufacturing, 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 skills.

Nice To Haves

Hands-on experience with 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, or 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 such as FDA, EMA, PMDA/JNDA, and TGA.
Demonstrated experience representing the organization at external conferences to influence wider industry standards.

Responsibilities

Serve as the senior technical authority for upstream vaccine process development and commercialization, providing 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 to deliver robust drug substance processes to internal and external GMP manufacturing sites in alignment with regulatory expectations and lifecycle plans.
Direct development and scale-up across platforms and equipment, including AMBR and other high-throughput microbioreactors, laboratory-scale stainless-steel and single-use systems, pilot-scale equipment, and commercial-scale manufacturing assets.
Ensure scale-down models are representative and scientifically justified.
Align and prioritize departmental technical, scientific, and business goals with broader enterprise priorities to support an evolving pipeline.
Manage team resource allocation, capital and consumable budgets, headcount projections, and financial targets.
Provide expert technical guidance across vaccine upstream process development and commercialization for large-molecule products.
Cultivate a high-performance culture by identifying, coaching, and developing talent and leveraging internal and external networks.
Evaluate team performance through structured formal appraisals and dedicated development support.
Establish succession plans and champion career advancement opportunities for high-potential talent.
Champion safety by role-modeling and reinforcing safe working practices through continuous training, Gemba walks, and EHS compliance.