Technical Manager - Peptide Development
External job listingat Perspective Therapeutics
Technical oversight of peptide programs, supporting development, manufacturing, GMP compliance, technology transfer, validation, and commercial readiness.
Salary
Not provided
Location
Somerset, United States
Employment type
Full time
Workplace
Not provided
Technical Manager - Peptide Development
Somerset, United States
Job description
About the role
Reporting to the Senior Director, CMC Operations, the CMC Technical Manager, Peptide Development provides technical oversight of peptide programs at CDMO manufacturing sites and in-house R&D activities. The role supports phase-appropriate development, disposition, and distribution of Perspective Therapeutics’ peptide-based radiopharmaceuticals across Phase I-III clinical and pre-commercial programs.
The role serves as a technical lead for late-stage peptide development and commercialization activities, including process scale-up, technology transfer, process validation, regulatory submissions, and commercial readiness. It also supports GMP compliance, quality-related activities, and technical oversight throughout clinical development and commercialization.
Responsibilities
- Oversee peptide programs at CDMO sites and support timely activities for peptide-based radiopharmaceutical drug candidates.
- Lead peptide CMC activities for 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, and specifications for early-phase clinical, late-phase clinical, and commercial peptide products.
- Manage technical and quality aspects of peptide development 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 development and manufacturing.
Key facts
- Reports to the Senior Director, CMC Operations.
- Oversees peptide programs at CDMO manufacturing sites and supports in-house R&D activities.
- Supports peptide-based radiopharmaceutical programs across Phase I-III clinical and pre-commercial programs.
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Frequently asked questions
What does this role involve?
It provides technical oversight of peptide programs and supports phase-appropriate development, disposition, and distribution of peptide-based radiopharmaceuticals.
What activities does the role lead?
Peptide CMC activities include process scale-up, technology transfer, process validation, and commercial readiness at internal and external manufacturing sites.
What quality activities are part of the role?
The role provides technical leadership for deviation investigations, CAPAs, change controls, product impact assessments, and disposition activities in partnership with QA.