Director, Large Molecule Analytical - GMP Operations

Merck•Rahway, NJ

5d•$173,200 - $272,600

About The Position

The Director, Large Molecule Analytical - GMP Operations 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 capabilities, 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, including batch-release and stability testing, raw-material and in-process testing, and analytical support for manufacturing. The role also leads GMP Operations participation in early-stage analytical method validation and the transition of methods from development into routine GMP use, in partnership with the Validation Strategy team. The position builds analytical readiness for new manufacturing capabilities by ensuring appropriate laboratory capacity, equipment, methods, materials, data systems, training, staffing, and technical expertise. It balances current operating demands with longer-term preparation for new facilities, technologies, and an expanding product portfolio. The Director maintains inspection readiness, manages quality and operational risks, leads responses to analytical events and method-performance issues, and partners across Manufacturing, Quality, analytical development, technical operations, and Regulatory teams. The role establishes performance measures and standardized practices to improve laboratory reliability, right-first-time execution, efficiency, and predictability. It also develops scientific and leadership talent, strengthens succession plans, and fosters an inclusive, high-performing organization.

Requirements

Ph.D. in analytical chemistry, biochemistry, biotechnology, pharmaceutical sciences, or a related discipline with 8 or more years of relevant pharmaceutical experience; or a master's degree with 10 or more years; or a bachelor's degree with 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.
Analytical Chemistry, Analytical Method Development, Analytical Testing, Antibody Drug Conjugates (ADC), Antibody Production, Biochemistry, Biological Manufacturing, Biologics, Biotechnology, Chromatographic Techniques, Monoclonal Antibodies, Monoclonal Antibody Development, Pharmaceutics, Process Analytical Technology (PAT), 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 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 maintain quality, scientific rigor, safety, data integrity, and accountability as the organization grows.
Lead batch-release and stability testing, ensuring timely, reliable, and compliant analytical results for product disposition and supply.
Oversee manufacturing analytical 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 methods from development into routine GMP use with the Validation Strategy team.
Provide laboratory and operational input to validation plans and prepare GMP Operations 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 immediate GMP operations with longer-term 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 arising from increased workload, new employees, new technologies, and expanded laboratory capabilities.
Provide technical and operational leadership for analytical events, method-performance issues, and other risks that may affect 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 create an inclusive, high-performing organization.