Objective
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 peptide development and commercialization activities, ensuring compliance with GMP standards, supporting quality investigations, and contributing to regulatory submissions as a subject matter expert. This is a hybrid role with required workdays in our Somerset, NJ office.

Essential Functions

• 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.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Education / Experience

• 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.
• PriorexperienceworkingwithCMCpeptideprogramsinregulatorysettings with external collaborators/vendors
• Technical writing experience to support CMC module 3.
• 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.

Knowledge / Skill / Ability

• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
• Full understanding of GMP and peptide manufacturing, methods validations, specifications, and release/stability.
• Strong project management skills, including contracting, budgeting, and timeline oversight.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Ability to multitask and manage parallel workstreams in a fast-paced drug development environment.
• Ability to travel up to 10%. Hybrid role in Somerset, NJ.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Willingness to complete safety training within allotted time limits, and work in a team-based environment.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.