Director, Biologics CMC Development

About the role

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. Here at Dechra, our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business. 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.

Responsibilities

• 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.
• Work 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.
• Cell Line and Process Development: Lead all aspects of cell line selection and development, clone selection, and cell culture process development activities.
• Oversee upstream and downstream process development, optimization, scalability assessments, and manufacturing readiness activities.
• Support process characterization, process robustness studies, comparability assessments, and control strategy development.
• Ensure development activities are aligned with regulatory expectations and commercial manufacturing requirements.
• Drive continuous improvement initiatives to enhance process performance, product quality, and development efficiency.
• CDMO/CRO Management and External Partnerships: Collaborate with Drug substance and Drug Product Operation leads to support activities related selection, management, and overseeing CDMO and CRO partners supporting biologics development programs.
• Provide scientific and operational leadership for outsourced development activities.
• Establish development plans, timelines, budgets, deliverables, and performance metrics with external partners.
• Lead technical reviews, governance meetings, risk assessments, and issue resolution activities.
• Build productive, long-term relationships with strategic development partners.
• CMC Development Support: Advance programs from discovery through IND-enabling, clinical, and commercial stages.
• Utilize Quality by Design (QbD) approaches including QTPP, CQA and process risk assessment tools for the development of a robust DS manufacturing process.
• Collaborate closely with analytical development, formulation development, manufacturing, and quality teams to ensure integrated CMC execution.
• Support manufacturing campaigns and provide technical leadership for investigations, process improvements, and