Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (Peptides)

Job Responsibilities

Lead and manage a team of scientists, providing technical guidance, mentorship, and performance management to achieve departmental goals.
Serve as the primary technical leader for peptide manufacturing processes, including synthesis and purification, resolving complex technical challenges and driving continuous improvement initiatives.
Oversee the transfer of new peptide processes from development to manufacturing, ensuring successful scale-up, validation, and regulatory compliance.
Design, execute, and interpret experiments to optimize existing peptide manufacturing processes, enhance yield, reduce cost, and improve product quality.
Author and review technical reports, protocols, and regulatory submissions related to peptide manufacturing processes and product quality.
Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless process execution and product delivery.
Lead investigations into manufacturing deviations, non-conformances, and out-of-specification results, implementing effective corrective and preventive actions (CAPAs).

Basic Qualifications

• B.S. in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline
• 8+ years of relevant experience in manufacturing within the pharmaceutical or biotechnology industry
• Proven leadership experience, including direct supervision and mentorship of scientific and technical staff.

Additional Preferences

• Strong understanding of cGMP regulations, ICH guidelines, and regulatory expectations for pharmaceutical manufacturing.
• Demonstrated ability to troubleshoot complex manufacturing issues and implement robust solutions.
• Excellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and concisely to diverse audiences.
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Able to work effectively in a fast-paced, dynamic, and highly collaborative environment.
• Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred.