Director, Large Molecule Analytical - GMP Operations

Job Description

Position Overview:

This 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, development of people and laboratory capability, and maintaining a strong quality and compliance culture throughout this period of significant growth.

Key Accountabilities:

• Lead and develop a growing team of 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 required to support significant growth in portfolio demand and laboratory scope.
• Establish clear expectations and operating practices that allow the organization to grow while maintaining a strong culture of quality, scientific rigor, safety, data integrity, and accountability.
• Provide leadership for batch-release and stability testing, ensuring timely, reliable, and compliant delivery of analytical results in support of product disposition and supply.
• Oversee analytical support for manufacturing, including raw-material and in-process testing for standard monoclonal antibody production in the Next Gen Bio facility, antibody-drug conjugate manufacturing, and sterile drug-product filling.
• Lead GMP Operations participation in early-stage analytical method validation and the transition of methods from development into routine GMP use, in partnership with the dedicated Validation Strategy team.
• Provide laboratory and operational input to validation plans authored by the Validation Strategy team and ensure the GMP Operations team is prepared to execute the studies reliably and transition validated methods into routine use.
• Build analytical readiness for new manufacturing capabilities, including the required laboratory capacity, equipment, methods, materials, data systems, training, staffing, and technical expertise.
• Balance the immediate demands of ongoing GMP operations with the longer-term work required to prepare for new facilities, technologies, and an expanding product portfolio.
• Maintain continual inspection readiness through robust documentation, disciplined laboratory practices, effective investigations, and timely corrective and preventive actions.
• Proactively identify and manage quality and operational risks associated with increasing workload, new employees, new technologies, and expanding laboratory capabilities.
• Provide technical and operational leadership for analytical events, method-performance issues, and other risks that could affect product quality, manufacturing schedules, regulatory commitments, or supply.
• Partner closely 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 that 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 capable of sustaining continued growth.

Qualifications and Experience:

• 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; experience with monoclonal antibodies, antibody-drug conjugates, or sterile products is preferred.
• 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.

Core Competencies and Skills:

• People leadership and organizational development
• GMP laboratory operations and inspection readiness
• Scientific judgment across biologics analytical platforms
• Operational planning, prioritization, and risk management
• Cross-functional influence and clear communication
• Change leadership and continuous improvement

Required Skills:

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)…