BioTalent have partnered with a growing biologics manufacturing organization to seek a strategic and experienced Senior Director of Manufacturing to oversee end-to-end operations across drug substance and drug product manufacturing. This role is critical to ensuring operational excellence, regulatory compliance, and scalability of biologics production in alignment with corporate growth objectives.
Key Responsibilities
- Lead and manage all manufacturing operations, including upstream and downstream processing, fill-finish, and packaging.
- Develop and execute manufacturing strategies to support clinical and commercial supply.
- Drive continuous improvement initiatives across productivity, cost, quality, and safety.
- Ensure compliance with cGMP, FDA, EMA, and other relevant regulatory standards.
- Collaborate cross-functionally with Quality, Supply Chain, Process Development, and Engineering teams.
- Oversee budgeting, resource planning, and capital projects within the manufacturing function.
- Build and mentor high-performing teams, fostering a culture of accountability and innovation.
- Represent manufacturing in audits, inspections, and partner interactions.
Qualifications
- Advanced degree in Life Sciences, Engineering, or related field (PhD, MS, or equivalent preferred).
- 12+ years of experience in biologics manufacturing, with at least 5 years in a senior leadership role.
- Proven track record in scaling GMP manufacturing operations for biologics (e.g., monoclonal antibodies, cell/gene therapies, recombinant proteins).
- Strong understanding of regulatory requirements and quality systems.
- Exceptional leadership, communication, and strategic planning skills.
Please reach out for more information - [email protected]
