Director, Large Molecule Analytical - GMP Operations

MSD • Rahway, NJ

8d • Onsite

About The Position

The Director will lead a growing GMP analytical team supporting biologics manufacturing in Rahway. The organization is expanding to support sterile drug-product filling, antibody-drug conjugate manufacturing, and standard monoclonal antibody production in the Next Gen Bio facility. The role is accountable for reliable analytical delivery, developing people and laboratory capability, and maintaining a strong quality and compliance culture during significant growth.

The Director will lead GMP analytical testing and manufacturing support across multiple biologics operations, while building the organizational structure, workforce plan, technical expertise, and leadership capacity needed for increased demand and laboratory scope. The role oversees batch-release and stability testing, analytical support for manufacturing, and GMP Operations’ participation in early-stage analytical method validation and the transition of methods into routine GMP use in partnership with the Validation Strategy team.

The position also builds analytical readiness for new manufacturing capabilities, balancing current operational demands with preparation for new facilities, technologies, and products. It maintains inspection readiness, manages quality and operational risks, and provides leadership for analytical events and method-performance issues. The Director partners with Manufacturing, Quality, analytical development, technical operations, and Regulatory teams, establishes performance measures and standardized practices, and develops scientific and leadership talent in an inclusive organization.

Requirements

• Ph.D. in analytical chemistry, biochemistry, biotechnology, pharmaceutical sciences, or a related discipline and 8 or more years of relevant pharmaceutical experience; or an M.S. and 10 or more years; or a B.S. and 14 or more 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.
• Strong knowledge of GMP requirements, data integrity, quality systems, and regulatory inspection expectations.
• Proven ability to lead through organizational growth, manage competing priorities, and deliver through cross-functional partnerships.
• Skills in people leadership and organizational development, GMP laboratory operations and inspection readiness, scientific judgment across biologics analytical platforms, operational planning and risk management, cross-functional influence and communication, and change leadership and continuous improvement.
• 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 Haves

• Broad knowledge of analytical technologies used for biologics drug substance and drug product.
• Experience with monoclonal antibodies, antibody-drug conjugates, or sterile products.

Responsibilities

• Lead and develop scientists and people leaders responsible for GMP analytical testing and manufacturing support across multiple biologics operations.
• Build the organizational structure, workforce plan, technical expertise, and leadership capacity needed to support growth in portfolio demand and laboratory scope.
• Establish operating expectations and practices that sustain quality, scientific rigor, safety, data integrity, and accountability during organizational growth.
• Lead batch-release and stability testing, ensuring timely, reliable, and compliant analytical results for product disposition and supply.
• Oversee analytical manufacturing support, including raw-material and in-process testing for monoclonal antibody production, antibody-drug conjugate manufacturing, and sterile drug-product filling.
• Lead GMP Operations participation in early-stage analytical method validation and transition of methods from development into routine GMP use with the Validation Strategy team.
• Provide laboratory and operational input to validation plans and prepare the GMP Operations team to execute studies and transition validated methods into routine use.
• Build analytical readiness for new manufacturing capabilities, including laboratory capacity, equipment, methods, materials, data systems, training, staffing, and technical expertise.
• Balance ongoing GMP operations with preparation for new facilities, technologies, and an expanding product portfolio.
• Maintain inspection readiness through robust documentation, disciplined laboratory practices, effective investigations, and timely corrective and preventive actions.
• Identify and manage quality and operational risks related to workload growth, new employees, new technologies, and expanded laboratory capabilities.
• Provide technical and operational leadership for analytical events, method-performance issues, and risks affecting product quality, manufacturing schedules, regulatory commitments, or supply.
• Partner with Manufacturing, Quality, analytical development, technical operations, and Regulatory teams to align testing priorities, capacity, readiness plans, and risk mitigation.
• Establish performance measures and standardized ways of working to improve laboratory reliability, right-first-time execution, efficiency, and predictability.
• Develop scientific and leadership talent, strengthen succession plans, and build an inclusive, high-performing organization.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director