Perspective Therapeutics

Game-changing therapies that make an impactful difference for cancer patients and the clinicians who treat them.

Technical Manager – Peptide Development

ManagerManagerFull TimeRemoteTeam 51-200Since 2023H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

158 days ago

Salary

Not specified

Bachelor Degree7 yrs expEnglish

Job Description

• 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.

Job 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

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