Technical Manager – Peptide Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all peptide programs at the CDMO, ensuring activities are completed promptly to support peptide-based radiopharmaceutical drug candidates.

• Review and approve master batch records, method validation protocols and reports, test methods, specifications, and other essential documents for early phase clinical, late phase clinical, and commercial peptide products.

• Manage the technical and quality components of clinical projects from raw materials through to manufacturing, packaging, distribution, and release/stability.

• Conduct ongoing reviews of batch records as part of product release, collaborating closely with quality on deviations and CAPAs, while ensuring effective communication regarding issues, developments, and plans.

• Collaborate with QA and early Discovery teams throughout the development and manufacturing processes.

• Ensure adherence to all relevant SOPs to support activities conducted at CDMOs.

• Serve as a Subject Matter Expert (SME) when necessary, providing or reviewing responses to regulatory agency findings from inspections.

• Draft and technically review IND/IMPD CMC sections, briefing packages, and any other regulatory submissions.

⛳️ Requirements

• A minimum of a B.S. degree in Chemistry, Biochemistry, or a related field.

• At least 7 years of experience in the Pharmaceutical Industry in a similar role.

• Previous experience with peptide synthesis, purification, and lyophilization.

• Experience working with CMC peptide programs in regulatory environments with external collaborators/vendors.

• Technical writing experience to support CMC module 3.

• Familiarity with Regulatory and Quality Assurance aspects of peptide product manufacturing processes.

• Experience in technical auditing and Radiopharmaceuticals is a plus.

• Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

🏝️ Benefits

• Health insurance

• Retirement plans