GMP Data Reviewer & Technical Writer

Objective

Reporting to the Senior Director, CMC Operations, the Scientist, GMP Data Reviewer & Technical Writer is responsible for supporting Perspective Therapeutics’ pipeline of radiopharmaceutical products, including radioisotope-labeled peptides and related biologics. This individual will lead and support phase-appropriate analytical method development, validation, and qualification activities. In addition, the role requires thorough review and interpretation of analytical data for raw materials, in-process controls, and finished product testing in compliance with GMP expectations.

Working in a fast-paced, integrated, and multidisciplinary environment, the successful candidate will bring a deep understanding of analytical instrumentation, regulatory standards, equipment qualification, method lifecycle management, and GMP documentation. The individual is expected to collaborate cross-functionally while also delivering strong independent contributions that support product advancement from clinical development to commercialization.

Essential Functions

• Lead or contribute to analytical method development, validation, and transfer efforts for clinical and commercial programs.
• Review, interpret, and approve raw data, laboratory reports, and validation documentation for accuracy and compliance with applicable GMP and ICH guidelines.
• Troubleshoot analytical issues and propose scientifically sound solutions in collaboration with internal teams and external partners.
• Contribute to cross-functional investigations (e.g., deviations, OOS, OOT) and author supporting documentation.
• Draft and revise technical protocols, method validation plans, SOPs, and final reports.
• Serve as subject matter expert for analytical instrumentation and associated software (e.g., HPLC, GC, UV-Vis, LSC).
• Collaborate with QA, QC, Manufacturing, and Regulatory teams to ensure project milestones and submission timelines are met.
• Support audits, inspections, and regulatory filings by providing documentation and responding to analytical inquiries.

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

• M.S in Analytical chemistry with 3+ years of relevant industry experience, or B.S. in Analytical Chemistry or related field with at least 5+ years of relevant industry experience in an FDA regulated laboratory environment .
• Minimum of 5 years of experience working in an FDA-regulated laboratory environment, with a strong understanding of cGMP standards.
• Deep expertise in regulatory frameworks (FDA, EMA), and commercial manufacturing compliance, with strong emphasis on quality, safety, and environmental impact.
• Demonstrated hands-on experience with method development and validation per ICH Q2 guidelines.
• Strong working knowledge of US and EU regulatory expectations for analytical controls and data integrity.
• Familiarity with quality systems, electronic lab systems, and document management systems.
• Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred.
• Experience with MS Office Suite required.

Knowledge / Skill / Ability

• Strong working knowledge of method validation principles, equipment qualification (IQ/OQ/PQ), and GMP laboratory operations.
• Experience reviewing data in alignment with GLP/GMP requirements, with a focus on accuracy, traceability, and compliance.
• Ability to prepare detailed study protocols and interpret complex datasets across multiple techniques.
• Excellent communication skills, including the ability to explain technical concepts to cross-functional teams.
• Prior radiochemistry experience and knowledge of radioactive material handling are a plus.
• Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines.
• Availability for occasional off-hours or weekend work as needed to support critical timelines.

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.
• May require travel up to 15%.