Associate Director - TS/MS Peptides

Role Summary

Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, specializing in Peptides. Provide technical leadership and scientific expertise to ensure robust and compliant manufacturing of peptide drug substances, from process development through commercialization and life cycle management.

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).
• Stay abreast of industry best practices, emerging technologies, and regulatory requirements related to peptide manufacturing and analytical methods.
• Present technical findings and recommendations to senior leadership and external stakeholders.

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.
• 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.
• Ability 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.

Education

• No additional education requirements beyond those listed in Basic Qualifications.

Additional Requirements

• Accommodation support available for applicants requiring assistance during the process.
• Travel requirements not specified; operationally relevant travel may be possible.