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 development and commercialization activities, ensuring compliance with GMP standards, supporting quality investigations, and contributing to regulatory submissions as a subject matter expert.

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.
• 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).

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 - 15%.

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.

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

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.