Associate Director, Biologics New Product Commercialization

Our Global Animal Health Manufacturing (GAHM) organization comprises internal production sites and external partners worldwide to supply products to customers globally. Animal Health offers veterinarians, farmers, pet owners, and governments a wide range of veterinary pharmaceuticals, vaccines, and health management solutions. The organization is dedicated to preserving and improving animal health, well-being, and performance while adhering to the highest standards of quality, professionalism, and integrity.

Our Global BioTechnology Support - Process Development (BTS-PD) group is accountable for technology transfer of new biopharmaceutical products from R&D to commercial production. This team leads critical technical activities such as scale-up, process validation/qualification, and process optimization to ensure successful product launches and maintain robust product supply. Processes are transferred to internal or external manufacturing (CDMO) partners, entailing strategic planning, risk management, change control, and Process Performance Qualification for regulatory filing and approval.

About the role

The Associate Director, Biologics New Product Commercialization for monoclonal antibodies (mAbs) is accountable for collaborating with technical subject matter experts (SMEs) in R&D and at manufacturing sites (internal and external) to transfer new veterinary mAb products from R&D into commercial manufacturing. This position provides matrix leadership of a cross-functional project team driving technology transfer and supporting product registration. The role involves project management from initial R&D contact through process transfer, Process Performance Qualification, regulatory filing, approval, and post-launch support. Reporting progress, escalating issues, and highlighting technical or project management risks to leadership are essential aspects of this position. This role can be located in Boxmeer (NL), Millsboro, DE (USA), or DeSoto, KS (USA).

Responsibilities

• Partner closely with other Biotechnical Support groups, R&D, and manufacturing sites (internal and external CDMOs) to enable on-time, right-first-time product launches.
• Drive effective project execution through robust planning of budgets, timelines, resources, and key milestones for new product transfers.
• Maintain oversight of project schedules, risks, and issue registers, escalating proactively to support successful delivery.
• Provide technical project management throughout the transfer lifecycle, including internal and CDMO process development, technical reviews, process risk assessments, technology transfers, and launches at internal and external manufacturing sites.
• Communicate project progress, risks, and key decisions clearly to senior stakeholders, governance bodies, and global project teams.
• Help shape and strengthen best practices, standards, and ways of working within your area of expertise.

Requirements

• Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, or related field with at least eight (8) years of relevant post-graduate experience, or
• Master of Science degree and at least six (6) years of relevant post-graduate experience, or
• Doctoral degree with at least four (4) years of relevant post-graduate experience.
• Minimum four (4) years of relevant experience as a project leader maintaining oversight, managing priorities, and delivering on-time results in a complex, fast-paced matrix organization within a regulated biopharmaceutical environment.
• At least two (2) years of relevant experience with external manufacturing sites (CDMOs).
• Strong expertise in technology transfer methodology and technical problem-solving, with the ability to turn complexity into practical solutions.
• Demonstrated effective collaboration with key stakeholders, including R&D, Manufacturing sites (internal and external), Analytical, Quality, Supply Chain, and Regulatory Affairs.

Preferred Qualifications

• Deep technical knowledge in mAb products and manufacturing processes.
• Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines.
• Strong working knowledge of key biopharmaceutical business processes, including Process Performance Qualification/Validation, risk assessments, CMC regulatory processes, and manufacturing change control.

Skills

• Required: External Manufacturing, Project Management, Project Management Execution, Strategic Planning, Technical Management, Technical Operations, Technical Projects, Technical Support, Technology Transfer Management.
• Preferred: Biopharmaceutical Industry, Biopharmaceutical Manufacturing, FDA Regulations, Food Manufacturing, Monoclonal Antibodies, Monoclonal Antibody Technology, Pharmaceutical Biotechnology, USDA Regulations.

Pay

The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• 10% travel requirements.
• First shift (day).
• Valid driving license required.