Director, Vaccines Drug Substance Commercialization - Upstream

Job description

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: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S.

Equal Opportunity Employment laws, visit

EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is: USA - Pennsylvania - West Point Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $173,200.00 - $272,600.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting.

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.

Please, no phone calls or emails.

Employee Status

Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 11/13/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.