Director, Biologics CMC Development

Director, Biologics CMC Development

The Director, Biologics CMC Development within the BioTherapeutics Innovation group will provide strategic and technical leadership for the development of biologic drug substance (DS) processes across the company's monoclonal antibody-based therapeutics pipeline. This individual will be responsible for leading cell line selection and development, upstream and downstream process development and related analytical method development both internally and through a network of contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs). As a key member of the CMC Leadership Team, the successful candidate will work collaboratively across Dechra R&D organization, Drug Substance Operations, Drug Product Operations, Clinical Development, Regulatory Affairs, Quality, Supply Chain and external partners to advance biologic candidates from research through clinical development and toward commercialization. The individual will play a critical role in building the CMC systems, processes, capabilities and external partnerships necessary to support pivotal clinical studies, regulatory submissions and commercial product launches.

This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

• Develop and execute integrated biologics CMC development strategies aligned with corporate and portfolio objectives.
• Serve as a key member of the CMC leadership team, contributing to organizational strategy, portfolio prioritization, resource planning, and capability development.
• Works closely with CMC director for biopharmaceutical development within DRD to develop streamlined development approaches.
• Support co-development activities working with the manufacturing, regulatory and other stakeholders.
• Define development approaches that balance scientific rigor through Quality by Design approaches, timeline, risk, cost, and long-term commercial requirements.
• Provide technical leadership and decision-making for biologics drug substance development programs.

The successful candidate will also be responsible for:

• Leading all aspects of cell line selection and development, clone selection, and cell culture process development activities.
• Overseeing upstream and downstream process development, optimization, scalability assessments, and manufacturing readiness activities.
• Supporting process characterization, process robustness studies, comparability assessments, and control strategy development.
• Ensuring development activities are aligned with regulatory expectations and commercial manufacturing requirements.
• Driving continuous improvement initiatives to enhance process performance, product quality, and development efficiency.

• Collaborating with Drug substance and Drug Product Operation leads to support activities related selection, management, and overseeing CDMO and CRO partners supporting biologics development programs.
• Providing scientific and operational leadership for outsourced development activities.
• Establishing development plans, timelines, budgets, deliverables, and performance metrics with external partners.
• Leading technical reviews, governance meetings, risk assessments, and issue resolution activities.
• Building productive, long-term relationships with strategic development partners.

• Supporting the advancement of programs from discovery through IND-enabling, clinical, and commercial stages.
• Utilized Quality by Design (QbD) approaches including QTPP, CQA and process risk assessment tools for the development of a robust DS manufacturing process.
• Collaborating closely with analytical development, formulation development, manufacturing, and quality teams to ensure integrated CMC execution.
• Supporting manufacturing campaigns and providing technical leadership for investigations, process improvements, and troubleshooting.

• Contributing to the preparation and review of regulatory submissions to FDA/USDA, EMA and other regulatory agencies.
• Authoring and reviewing drug substance sections of regulatory documents and technical reports.
• Participating in health authority interactions and inspections as a subject matter expert, as appropriate.
• Ensuring development activities meet applicable quality, GMP, and regulatory requirements.

• Helping establish and strengthen CMC development systems, workflows, governance processes, and technical standards.
• Building organizational capabilities to support a growing biologics portfolio through late-stage development and commercialization.
• Mentoring and developing scientists and project team members.
• Fostering a culture of scientific excellence, innovation, accountability, and cross-functional collaboration.

• Deep expertise in biologics drug substance development, including cell line development, upstream process development, and downstream purification.
• Working knowledge of process characterization, and manufacturing scale-up.
• Demonstrated experience managing development and manufacturing activities at CDMOs and CROs.
• Experience supporting biologics programs through IND-enabling studies, clinical development, and commercialization.
• Strong understanding of regulatory expectations for biologics CMC development.
• Understanding of animal health related regulations will be an advantage.
• Experience with monoclonal antibodies, recombinant proteins, fusion proteins, or other biologics modalities is highly desirable.
• Knowledge of Quality by Design (QbD), process validation, control strategies, and lifecycle management principles.

The Ideal Candidate Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:

• Minimum 9+ years of biotechnology or pharmaceutical industry experience with significant experience in biologics drug product development and manufacturing.
• Ph.D. in Pharmaceutical Sciences, Life Sciences, Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Molecular Biology, or related scientific discipline required.
• Additional industry experience may be considered in lieu of certain educational requirements.
• Understanding of the science and technology underlying Biologics Drug Substance manufacturing platforms including fed-batch/continuous manufacturing and technology transfer.
• Demonstrated understanding of the technical aspects of development and Quality by Design (QbD) approach will be essential
• Good working knowledge of biopharmaceutical Drug Substance process development, manufacturing and analytical development/quality control.
• Working experience in negotiating and executing process development activities.
• Ability to travel (domestic/international) approximately 25-30%.
• The candidate should be comfortable working in a virtual project team environment.