Technical Manager – Peptide Development

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October 7

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Perspective Therapeutics

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Perspective Therapeutics is a biotechnology company focused on developing innovative cancer treatments through a unique class of theranostics. Their proprietary technologies enable the targeting of specific tumors for treatment while minimizing toxicity to healthy tissues. By utilizing radiation, radiopharmaceuticals, and advanced imaging technologies, they aim to improve treatment efficacy and provide better outcomes for cancer patients.

51 - 200 employees

Founded 2023

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $400k Grant on 2024-02

📋 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.

🎯 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