Director, Vaccines Drug Substance Commercialization - Upstream (Vaccines)

Location: West Point, Pennsylvania, United States; flexible work arrangements are not applicable. The posting is for residents of the United States, Canada, and Puerto Rico.

Salary: $173,200–$272,600 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global develops and manufactures pharmaceutical and vaccine products through its Manufacturing Division.

What you will do

• Lead a team of approximately 30 scientists and engineers within Vaccines Drug Substance Commercialization Upstream.
• Provide scientific and technical leadership for mammalian cell culture, live-virus vaccines, microbial fermentation, media and feed strategy, bioreactor engineering, process intensification, scale-up, characterization, technology transfer, validation, and lifecycle management.
• Drive process control and validation strategies for internal and external GMP manufacturing sites, aligned with regulatory expectations and lifecycle plans.
• Direct process development and scale-up across microbioreactors, stainless-steel and single-use laboratory systems, pilot equipment, and commercial manufacturing assets.
• Set departmental technical, scientific, business, resource, capital, and consumable priorities while managing budgets and headcount projections.
• Develop talent and succession plans, manage performance, and reinforce EHS and compliance practices.

Requirements

• Ph.D. or Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, Biochemistry, or a related field.
• 10+ years of experience leading end-to-end vaccine and/or biologic CMC process development, including late-stage projects, regulatory filings, and approvals.
• 5+ years leading CMC projects and directing transversal or functional process development teams, including large laboratory-based process development and technology transfer teams.
• Deep expertise in biologics and/or vaccine processing, with the ability to independently direct cell culture and fermentation process commercialization.
• Experience authoring CMC technical documentation, including PPQ, risk assessments, control strategies, comparability reports, and regulatory filings.
• Exceptional interpersonal, communication, matrix-leadership, mentoring, and timeline-management skills.

Nice to have

• Hands-on experience with fermentation and cell culture, including intensified inoculum, fed-batch, and perfusion development.
• Experience with stainless-steel systems, high-throughput microbioreactors, and in situ analytics for real-time monitoring.
• Experience with predictive modeling, data science, metabolic flux analysis, omics, machine learning, and process analytical technology.
• Background in mathematical scaling, computational fluid dynamics, Quality by Design, and Lean Six Sigma.
• Direct GMP manufacturing support, including batch record reviews and operational oversight.
• Experience with international filings such as IND, MAA, and BLA and interactions with FDA, EMA, PMDA/JNDA, and TGA.
• Experience representing the organization at external conferences and influencing industry standards.

Culture & Benefits

• Regular employee position with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, compassionate, and sick days.
• Inclusive environment focused on diverse perspectives, respectful challenge, collaboration, and innovation.
• Travel requirement: 10%.
• Visa sponsorship is not available.
• Applications are accepted through November 12, 2026, because the posting ends on November 13, 2026.