Director/Principal Scientist, Biologics Drug Substance Commercialization

About the role

Merck's Manufacturing Division, in its Biologics Drug Substance Commercialization (BDSC) team, is looking for a Principal Scientist/Director to lead upstream cell culture and commercialization for late-stage and commercial biologics programs. The role drives licensure and commercial manufacturing through process characterization, technology transfer and validation, and oversees a team of scientists. It is based in West Point, Pennsylvania.

Key responsibilities

• Lead upstream and/or integrated drug substance teams for late-stage clinical and commercial programs, with a clear line of sight to licensure and commercialization.
• Provide technical leadership for laboratory-scale and manufacturing-scale studies covering process characterization, validation, investigations and continued process verification.
• Act as upstream subject matter expert across core unit operations, with an understanding of downstream, analytical and GMP interdependencies.
• Ensure process and product knowledge is developed, documented and transferred in line with company standards and regulatory expectations.
• Support technology transfer to internal and external manufacturing sites, including scale-up, process validation and manufacturing readiness.
• Contribute to manufacturing investigations and lifecycle management, and author and review technical and regulatory documentation, including regulatory submission content.
• Drive division-wide initiatives, multi-year planning and representation on cross-functional teams, and collaborate with internal stakeholders and external partners such as CDMOs.
• Lead, coach and mentor a team of upstream scientists, support resource planning and hiring, and build a talent pipeline.

Required profile

• BS, MS or PhD in Chemical, Biological or Biochemical Engineering or a related discipline.
• 16+ years of industry experience (BS), 12+ years (MS) or 8+ years (PhD).
• Deep expertise in cell culture process development and commercialization, with proven ability to design, direct, execute, analyze and document process development.
• Experience supporting biologics commercialization, including late-stage development and/or commercial manufacturing.
• Proven leadership, collaboration and mentoring skills in cross-functional, matrixed organizations.

Required skills

• Process development, process characterization, process validation and scale-up.
• Preferred: hands-on experience with technology transfer, multi-specific antibody therapeutics, viral clearance studies, PPQ, regulatory submissions (e.g. BLA sections) and cGMPs.

What we offer

• Base salary range of $173,200 to $272,600, with eligibility for annual bonus and long-term incentives.
• Medical, dental, vision and other insurance, retirement benefits including 401(k), paid holidays, vacation and compassionate and sick days.
• Relocation support for domestic moves; visa sponsorship is not offered.