Director, Biologics CMC Development

Role Responsibility

So, what will you be doing? 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.

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 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. 
• 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 troubleshooting.

Regulatory and Quality Support

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

Organizational and Capability Building

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

Technical Expertise

• 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.