Perspective Therapeutics

Manager

• 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 development and commercialization activities, ensuring compliance with GMP standards.
• Responsible for overseeing all the peptide programs at CDMO and ensuring the activities are completed in a timely manner to support peptide based radiopharmaceutical drug candidates.
• Responsible for review and approval of 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 clinical projects from raw materials to manufacturing to packaging, distribution and release/stability.
• Perform ongoing review of batch records as part of product release, working closely with quality on deviations and CAPAs, and ensuring appropriate communication of issues, development and plans.
• 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.
• Acting as SME when needed and in providing or reviewing responses to regulatory agency findings from inspections.
• Draft and technical review of IND/IMPD CMC sections, briefing packages, and any other regulatory submissions.

Perspective Therapeutics

Technical Manager – Peptide Development

Director, Site Facilities and Engineering