Technical Manager – Peptide Development

Job Description

• Technical Manager leading peptide CMC programs for peptide-based radiopharmaceutical clinical and commercial products at CDMOs and internal R&D sites in a hybrid Franklin Township, NJ role.
• Lead scale-up, technology transfer, process validation, manufacturing controls, regulatory submissions, quality activities, and commercial readiness through late-stage clinical development and commercialization.
• Review and approve master batch records, validation protocols and reports, test methods, specifications, and IND/IMPD CMC sections; support deviations, CAPAs, change controls, investigations, inspections, and product disposition.
• Requires a B.S. in Chemistry, Biochemistry, or a related field and 7+ years of pharmaceutical industry experience in a similar function, including peptide synthesis, purification, and lyophilization.
• Requires GMP, ICH Q10, quality systems, regulatory, project management, Microsoft Office, communication, and organizational skills; requires up to 15% travel, radioactive-materials facility work, and completion of safety training.