Associate Director, Biologics New Product Commercialization

Job Description 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. This role can be located in Boxmeer (NL), Millsboro, DE (USA) or DeSoto, KS (USA). Your role The Associate Director, Biologics New Product Commercialization for monoclonal antibodies (mAbs) is accountable for 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. This position provides matrix leadership of a cross-functional project team that drives technology transfer and supports product registration. This critical role provides 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 are also an essential aspect of this position. Job Responsibilities Partner closely within other Biotechnical Support groups, R&D, and manufacturing sites (internal & 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, and accelerate proactively to support successful delivery. Provide 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. 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. Required Qualifications 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. 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 Required Skills External Manufacturing Project Management Project Management Execution Strategic Planning Technical Management Technical Operations Technical Projects Technical Support Technology Transfer Management Preferred Skills Biopharmaceutical Industry Biopharmaceutical Manufacturing FDA Regulations Food Manufacturing Monoclonal Antibodies Monoclonal Antibody Technology Pharmaceutical Biotechnology USDA Regulations Salary 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. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Benefits We offer a comprehensive package of benefits. Available benefits include 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 . Inclusion and EEO US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts Relocation and Travel Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Job Posting End Date: 09/11/2026 Location This role can be located in Boxmeer (NL), Millsboro, DE (USA) or DeSoto, KS (USA). #J-18808-Ljbffr Biopharma Careers