Project Manager - Pharmaceutical Manufacturing

Astrix; Brownsburg (IN); On-site; USD 62,000 - 83,000; Full time

Job summary

Astrix is seeking a Project Manager for a Brownsburg, IN onsite role to lead critical manufacturing and operational readiness initiatives at a specialized pharmaceutical facility. The candidate will align facility design with CMC, IND submissions, Phase III studies, NDA, and FDA PAI requirements.

The role requires 5+ years of PM experience in pharma/biotech, strong GMP knowledge, and the ability to coordinate across Manufacturing, Quality, Regulatory, and Engineering teams to ensure regulatory

Qualifications

• 5+ years of project management in pharma/biotech or related settings.
• GMP manufacturing operations knowledge and equipment qualification experience.
• Familiarity with CMC requirements and regulatory expectations.

Responsibilities

• Lead manufacturing readiness initiatives, technology transfers, and new product introductions.
• Coordinate cross-functional teams across Manufacturing, Quality, Regulatory Affairs, CMC, Safety, and Engineering.
• Oversee facility design, qualification activities, and process readiness to GMP standards.
• Ensure regulatory alignment, validation planning, documentation, and inspection readiness.
• Identify risks and roadblocks, develop mitigations, and drive timely resolution.
• Manage project timelines, milestones, resources, and deliverables across teams.
• Support preparation for regulatory milestones including IND/Phase III/NDA submissions and FDA inspections.
• Establish governance and continuous improvement in manufacturing readiness initiatives.

Education

Bachelor's or Master's degree in Pharmaceutical Engineering or related technical discipline

Job description

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 - Pharmaceutical Manufacturing

Location: Brownsburg, IN (Onsite)

Salary range: $45/hr - $60/hr+ (Flex Dependent on experience level)

6-month contract to hire

Position Overview

We are seeking a 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.

Qualifications

• Bachelor or Master's degree in Pharmaceutical Engineering, Mechanical Engineering, Process Engineering, or a related technical discipline.
• 5+ years of experience in pharmaceutical, biotechnology, medical device, 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.