What are the responsibilities and job description for the CMC Project Manager - Radiopharmaceutical position at Astrix?
Our client is a biotechnology company specializing in radiopharmaceutical development and targeted cancer therapies. The organization leverages advanced radiochemistry and drug development technologies to develop innovative treatments for patients with significant unmet medical needs.
Title: Project Manager – Radiopharmaceutical Manufacturing
Location: Brownsburg, IN (Onsite)
Employment Type: Full-Time
Travel: Domestic and international travel as needed
Salary range: $80,000 - $125,000 (Dependent on experience level)
Position Overview
We are seeking a Senior Project Manager to lead critical manufacturing and operational readiness initiatives at a specialized pharmaceutical manufacturing facility focused on innovative cancer therapies.
In addition to managing projects, this role will play a key part in ensuring that the facility and process design are aligned with CMC development and regulatory requirements, particularly for the IND submission, upcoming Phase III clinical studies, NDA submission, and FDA Pre-Approval Inspection (PAI).
Key Responsibilities
Education: Master's degree in Pharmaceutical Engineering, Mechanical Engineering, Process Engineering, or a related technical discipline.
Title: Project Manager – Radiopharmaceutical Manufacturing
Location: Brownsburg, IN (Onsite)
Employment Type: Full-Time
Travel: Domestic and international travel as needed
Salary range: $80,000 - $125,000 (Dependent on experience level)
Position Overview
We are seeking a Senior Project Manager to lead critical manufacturing and operational readiness initiatives at a specialized pharmaceutical manufacturing facility focused on innovative cancer therapies.
In addition to managing projects, this role will play a key part in ensuring that the facility and process design are aligned with CMC development and regulatory requirements, particularly for the IND submission, upcoming Phase III clinical studies, NDA submission, and FDA Pre-Approval Inspection (PAI).
Key Responsibilities
- Lead cross-functional projects supporting manufacturing readiness, technology transfers, new product introductions, and the transition to commercial production.
- Partner with Manufacturing, Quality, Regulatory Affairs, CMC, Safety, and Engineering teams to align project execution with clinical and commercial objectives.
- Oversee initiatives related to GMP-compliant facility design, manufacturing infrastructure, equipment qualification, and process readiness.
- Ensure project plans account for regulatory requirements, validation activities, documentation, and inspection readiness.
- Identify project risks, operational gaps, and potential roadblocks; develop mitigation strategies and drive timely resolution.
- Coordinate project timelines, milestones, resources, and deliverables across multidisciplinary teams.
- Support preparation for key regulatory milestones, including late-stage clinical studies, commercial product submissions, and FDA inspections.
- Establish project governance practices, maintain clear documentation, and drive continuous improvement across manufacturing readiness initiatives.
Education: Master's degree in Pharmaceutical Engineering, Mechanical Engineering, Process Engineering, or a related technical discipline.
- 10 years of experience in pharmaceutical, radiopharmaceutical, nuclear, or other complex process manufacturing environments.
- 5 years of direct project management experience.
- Strong understanding of GMP manufacturing operations and the design, commissioning, qualification, and validation of manufacturing equipment and systems.
- Knowledge of specialized pharmaceutical manufacturing infrastructure, including hot cells, critical facility systems, and aseptic manufacturing environments.
- Familiarity with Chemistry, Manufacturing, and Controls (CMC) requirements and regulatory expectations for clinical and commercial manufacturing.
Salary : $80,000 - $125,000