Director, Large Molecule Analytical - GMP Operations (Biologics)

Location: Rahway, New Jersey, United States. Onsite role; flexible work arrangements are not applicable. Domestic relocation is available, visa sponsorship is available, and travel requirements are 10%.

Base salary: $173,200–$272,600 per year, plus eligible annual bonus and long-term incentive.

Company

hirify.global develops pharmaceutical products and operates biologics manufacturing and GMP analytical organizations.

What you will do

• Lead and develop scientists and people leaders responsible for GMP analytical testing and manufacturing support across biologics operations.
• Build the organizational structure, workforce plan, laboratory capacity, equipment, methods, data systems, training, staffing, and technical expertise needed for expanding manufacturing capabilities.
• Oversee batch-release, stability, raw-material, and in-process testing for monoclonal antibodies, antibody-drug conjugates, and sterile drug-product filling.
• Lead GMP Operations participation in analytical method validation and transition validated methods from development into routine GMP use.
• Maintain inspection readiness through disciplined laboratory practices, documentation, investigations, corrective and preventive actions, and data integrity controls.
• Partner with Manufacturing, Quality, analytical development, technical operations, and Regulatory teams to manage priorities, capacity, readiness, and risks.

Requirements

• Ph.D. in analytical chemistry, biochemistry, biotechnology, pharmaceutical sciences, or a related discipline with 8+ years of relevant pharmaceutical experience; or MS with 10+ years; or BS with 14+ years.
• Demonstrated leadership of scientists or laboratory teams in a GMP-regulated biologics environment.
• Experience with biologics analytical testing, including method validation, manufacturing support, batch release, stability, investigations, and laboratory lifecycle management.
• Broad knowledge of analytical technologies used for biologics drug substance and drug product.
• Strong knowledge of GMP requirements, data integrity, quality systems, and regulatory inspection expectations.
• Ability to lead through organizational growth, manage competing priorities, and deliver through cross-functional partnerships.
• Required skills include analytical chemistry, analytical method development, analytical testing, antibody-drug conjugates, antibody production, biochemistry, biological manufacturing, biologics, biotechnology, chromatographic techniques, monoclonal antibodies, monoclonal antibody development, pharmaceutics, process analytical technology, and regulatory submissions.

Nice to have

• Experience with monoclonal antibodies, antibody-drug conjugates, or sterile products.

Culture & Benefits

• Regular employee status with first-shift, daytime work.
• Benefits include medical, dental, vision, insurance for employees and families, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.
• Work in an inclusive environment focused on quality, scientific rigor, safety, data integrity, accountability, and continuous improvement.
• No valid driving license is required; hazardous materials are not applicable.

Hiring process

• Applications are accepted through the hirify.global careers site; the posting is effective until 11:59 p.m. on November 12, 2026.
• The role is intended for residents of the United States, Canada, and Puerto Rico; residents of other markets should use the applicable MSD Careers site.