Senior Manager, Strategy
TCGplayer (an eBay company)
Technical Manager – Peptide Development
Perspective Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
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 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.
Requirements
- Minimum B.S degree in Chemistry, Biochemistry or related field is required.
- 7+ years’ experience in 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.
- Familiarity with Regulatory and Quality Assurance aspects in manufacturing processes of peptide products.
- Technical auditing and Radiopharmaceutical experience are a plus.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Benefits
- Health insurance
- Flexible working hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
peptide synthesispurificationlyophilizationGMP compliancemethod validationtest methodsspecificationstechnical auditingregulatory submissionsCMC development
Soft skills
communicationleadershiporganizational skillsproblem-solvingcollaboration
