Technical Manager - Peptide Development

About the role

Reporting to the Senior Director, CMC Operations, the CMC Technical Manager, Peptide Development is responsible for the technical oversight of peptide programs at CDMO manufacturing sites and in-house R&D activities. This role supports phase-appropriate development, disposition, and distribution of Perspective Therapeutics’ peptide-based radiopharmaceuticals across Phase I-III clinical and pre-commercial programs. The individual will serve as a key technical lead for late-stage peptide development and commercialization activities, including process scale-up, technology transfer, process validation, regulatory submissions, and commercial readiness efforts.

Responsibilities

• Oversee all peptide programs at CDMO and ensure activities are completed in a timely manner to support peptide-based radiopharmaceutical drug candidates.
• Lead peptide CMC activities supporting process scale-up, technology transfer, process validation, and commercial readiness at internal and external manufacturing sites.
• Review and approve master batch records, method validation protocols and reports, test methods, specifications, etc. for early phase clinical, late phase clinical, and commercial peptide products.
• Manage the technical and quality aspects of peptide development programs from raw materials through manufacturing, packaging, distribution release, and stability, ensuring phase-appropriate GMP compliance and inspection readiness.
• Provide technical leadership for batch record review, deviation investigations, CAPAs, change controls, product impact assessments, and disposition activities in partnership with Quality Assurance (QA).
• Work closely with QA and early Discovery organizations throughout the development and manufacturing processes.
• Ensure all relevant SOPs are followed to support activities carried out at CDMOs.
• Act as subject matter expert (SME) when needed and provide or review responses to regulatory agency findings from inspections.
• Draft and perform technical review of IND/IMPD CMC sections, briefing packages, and other regulatory submissions.

This is a hybrid position that will require travel to manufacturing sites.

Requirements

• Minimum B.S. degree in Chemistry, Biochemistry, or related field.
• 7+ years’ experience in the pharmaceutical industry in a similar function.
• Prior experience with peptide synthesis, purification, and lyophilization.
• Prior experience working with CMC peptide programs in regulatory settings with external collaborators/vendors.
• Technical writing experience to support CMC module 3.
• Familiarity with Regulatory and Quality Assurance aspects in manufacturing processes of peptide products.
• Technical auditing and radiopharmaceutical experience are a plus.

Skills

• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
• Full understanding of GMP and peptide manufacturing, methods validations, specifications, and release/stability.
• Deep understanding of peptide process development, scale-up, manufacturing controls, and commercialization requirements for late-stage clinical and commercial products.
• Strong project management skills, including contracting, budgeting, and timeline oversight.
• Excellent communication skills (verbal and written).
• Highly organized with strong attention to detail, clarity, accuracy, and conciseness.
• Ability to multitask and manage parallel workstreams in a fast-paced drug development environment.
• Ability to travel up to 15%.

Work Environment

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Willingness to complete safety training within allotted time limits and work in a team-based environment.