Associate Director, Biologics New Product Commercialization

Merck • Millsboro, DE

1d • $142,400 - $224,100 • Hybrid

About The Position

Our Global Animal Health Manufacturing (GAHM) organization comprises of internal production sites and external partners throughout the world, to supply our products to customers around the globe. Animal Health offers veterinarians, farmers, pet owners and governments the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Animal Health is dedicated to preserving and improving the health, well-being, and performance of animals while conducting its business according 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 & robustness to ensure successful product launches and maintain robust product supply. In addition, processes need to be transferred to manufacturing site, either internal or with external manufacturing (CDMO) partners. This entails strategic planning and risk management, change control, Process Performance Qualification towards regulatory filing and approval.

Requirements

• Bachelors 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 a Doctoral degree with at least four (4) years of relevant post-graduate experience
• Minimum four (4) years of relevant experience as a project leader who can maintain oversight, manage priorities, and deliver on-time results in a complex, fast-paced matrix organization; 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 & external), Analytical, Quality, Supply Chain and Regulatory Affairs.

Nice To Haves

• 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

Responsibilities

• Collaborating with technical SMEs in R&D and at manufacturing sites (internal and external) to transfer new veterinary mAb products from R&D into commercial manufacturing sites.
• Providing matrix leadership of a cross-functional project team that drives technology transfer and supports product registration.
• Providing project management from the first point of contact with R&D through process transfer, Process Performance Qualification, regulatory filing and approval and post-launch support.
• Reporting progress, escalating issues and highlighting Technical or project management risks to leadership.
• Partnering closely within other Biotechnical Support groups, R&D, and manufacturing sites (internal & external CDMOs) to enable on-time, right-first-time product launches.
• Driving effective project execution through robust planning of budgets, timelines, resources and key milestones for new product transfers.
• Maintaining oversight of project schedules, risks and issue registers, and escalating proactively to support successful delivery.
• Providing technical project management throughout the transfer lifecycle, including: internal & CDMO process development, technical reviews, process risk assessments, technology transfers and launches at Internal and External Manufacturing sites.
• Communicating project progress, risks and key decisions clearly to senior stakeholders, governance bodies and global project teams.
• Helping shape and strengthen best practices, standards and ways of working within your area of expertise.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

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