Director, MSAT-Drug Product (Biologics)

Location: Princeton, NJ, United States

Salary: $203,000–$253,000 USD per year; total compensation may also include bonus, stock, benefits, and other variable compensation.

Company

hirify.global is a biopharmaceutical oncology company developing investigational therapies and conducting global Phase 3 studies in non-small cell lung cancer and colorectal cancer.

What you will do

• Lead sterile drug product process development and characterization, technology transfer, and process validation, including oversight of CDMOs and internal teams.
• Lead a small drug product team and support clinical and commercial batch manufacturing in line with development and supply timelines.
• Co-author CMC chapters for BLA, IND, and IMPD submissions and ensure data integrity, technical compliance, and GMP compliance.
• Support regulatory agency interactions, PLI/PAI preparation and delivery, audits, and inspections.
• Coordinate process, product, and site changes with CMC, Regulatory, Quality, Supply Chain, CRO, and CDMO stakeholders.
• Prioritize post-approval opportunities and develop business cases for productivity improvements, scale-up, and scale-out.

Requirements

• MSc in Engineering, Biochemistry, Pharmaceutical Sciences, or a related field; PhD preferred.
• 10+ years of experience in biologics manufacturing, including sterile drug product and late-phase development.
• Proven experience with BLA preparation, PPQ, and commercial launch.
• Strong knowledge of FDA and EMA regulatory expectations for biologics and sterile drug products.
• Experience managing CDMO partners and internal cross-functional teams.
• Excellent leadership, communication, project management, collaboration, and inclusion skills.
• Ability to manage multiple projects while maintaining high-quality results and implement innovative solutions to urgent and complex situations.

Culture & Benefits

• Work within a collaborative CMC, regulatory, quality, and supply chain environment focused on oncology clinical development and commercialization.
• Summit emphasizes integrity, excellence, purposeful urgency, collaboration, and commitment to people.
• Compensation may include bonus, stock, benefits, and other applicable variable compensation.
• Summit is an Equal Opportunity Employer and maintains a diverse, non-discriminatory workplace.

Hiring process

• Summit does not accept referrals from employment businesses or agencies without prior written authorization from its Talent Acquisition team.