Director, Vaccines Drug Substance Commercialization - Upstream
Merck · United States, Pennsylvania, West Point
Job Description
As part of Our Company’s Manufacturing Division, within the Vaccines Drug Substance Commercialization (VDSC) organization, the Upstream department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for the upstream portion of vaccines drug substance processes. VDSC supports various commercialization activities and second-generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.
Under the scientific and administrative direction of the Executive Director, VDSC, and working in close partnership with internal and external stakeholders, you will lead a highly skilled team of ~30 scientists and engineers. In this pivotal leadership role, you will shape the commercialization strategies for late-stage pipelines and champion post-market commercial manufacturing commitments to deliver life-saving vaccines globally.
In this role, the successful candidate will be responsible as the Director for:
- Scientific Oversight: Serve as the senior technical authority for upstream vaccine process development and commercialization. Provide technical direction across mammalian cell culture, live-virus vaccines (host cell and virus biology, infection kinetics, etc), microbial fermentation, media and feed strategy, bioreactor engineering, process intensification, scale-up, process characterization, technology transfer, validation, and lifecycle management.
- Technical & Manufacturing Delivery: Drive process control and validation strategies to deliver robust drug substance processes to both internal and external GMP manufacturing sites, ensuring full alignment with regulatory expectations and lifecycle plans.
- Platform and Scale Translation: Direct development and scale-up across varied 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.
- Strategic Leadership: Align and prioritize departmental technical, scientific, and business goals with broader enterprise priorities to dynamically support an evolving pipeline.
- Financial & Resource Management: Own accountability for team resource allocation, capital, and consumable budgets, ensuring headcount projections and financial targets are met precisely.
- Subject Matter Expertise: Provide expert technical guidance across all aspects of vaccine upstream process development and commercialization for large molecule products.
- Talent Development: Cultivate a high-performance culture by identifying, coaching, and developing talent; actively leveraging both internal and external networks.
- Performance Management: Evaluate team performance accurately through structured, formal appraisal processes and dedicated development support.
- Succession Planning: Establish robust succession plans and actively champion career advancement opportunities for high-potential talent.
- EHS & Compliance: Champion a culture of safety by actively role-modeling, reinforcing, and implementing safe working practices through continuous training, Gemba walks, and EHS compliance.
Required (Basic) Qualifications
Candidates must meet these criteria to be considered for the role.
- Education Experience: Ph.D. or Master’s in Chemical Engineering, Bioengineering, Biological Engineering, Biochemistry or a related field.
- Industry Experience: 10+ years of experience leading end-to-end vaccine and/or biologic CMC process development, with a strong emphasis on late-stage projects, regulatory filing, and approvals.
- Leadership Scope: 5+ years of experience leading CMC projects and directing transversal or functional process development teams. Proven track record managing large, lab-based process development and tech transfer teams.
- Technical Expertise: Deep subject matter expertise in biologics and/or vaccine processing (large molecules), with the ability to independently direct all stages of cell culture and fermentation process commercialization.
- Regulatory & Documentation: Proven experience authoring critical CMC technical documentation, including Process Performance Qualification (PPQ), risk assessments, control strategies, comparability reports, and regulatory filings.
- Soft Skills & Agility: Exceptional interpersonal, communication, and matrix-leadership skills with a proven ability to mentor staff, drive a high-performance culture, and deliver on tight timelines.
Preferred Qualifications
These credentials will distinguish highly competitive candidates.
- Process Technology: Hands-on experience with both fermentation and cell culture, including intensified inoculum, fed-batch, and perfusion process development.
- Equipment & Analytics: Experience with stainless steel systems, high-throughput microbioreactors, and advanced in situ analytics for real-time process monitoring.
- Data Science & Modeling: Experience with predictive modeling and data science (e.g., Metabolic Flux Analysis (MFA), omics, machine learning) and integrating Process Analytical Technology (PAT).
- Engineering & Quality: Strong background in mathematical scaling, Computational Fluid Dynamics (CFD), Quality by Design (QbD), and Lean Six Sigma principles.
- On-the-Floor GMP: Experience providing direct GMP manufacturing support, including batch record reviews and operational oversight.
- Global Regulatory Exposure: Direct experience supporting and writing international regulatory filings (IND, MAA, BLA) and interacting with global health authorities (FDA, EMA, PMDA/JNDA, TGA).
- External Influence: Demonstrated experience representing in external conferences to influence wider industry standards.
Required Skills:
Analytical Thinking, Clinical Manufacturing, Driving Continuous Improvement, Employee Development, Good Manufacturing Practices (GMP), Manufacturing Equipment, People Leadership, Pharmaceutical Process Development, Process Characterization, Process Development (PD), Process Validation, Resource Management, Results-Oriented, Strategic Planning, Technical Leadership, Upstream Process Development, Vaccine Manufacturing
Preferred Skills:
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