🚀 Senior Manager, Radiochemist - CMC

We have a current opportunity for a Senior Manager, Radiochemist - CMC on a permanent basis. For further information about this position please apply.

Position Overview

Reporting to the Senior Director of PET Operations, the Senior Manager, Radiochemist - CMC will lead the daily operations of a U.S.-based network of third-party Contract Manufacturing Organizations (CMOs) focused on PET radiopharmaceutical production. This role will also contribute to the strategic development and expansion of domestic PET Manufacturing Facilities. The ideal candidate will bring strong leadership, operational expertise, and cross-functional collaboration skills to ensure consistent, high-quality supply of radiopharmaceuticals.

Key Responsibilities

CMO Oversight

• Manage daily batch production and resolve synthesis or logistics issues quickly.
• Communicate supply disruptions and monitor quality-related concerns.
• Assess product demand vs. site capacity and adjust plans accordingly.
• Track and report key performance indicators (KPIs) for each CMO.

Project & Stakeholder Management

• Support development projects and coordinate implementation with third-party manufacturers.
• Act as the technical liaison between internal teams and CMOs during setup and post-approval phases.

Technology Transfer

• Lead technology transfer from development to commercial manufacturing.
• Ensure thorough documentation, training, and cross-functional alignment.
• Monitor post-transfer performance and troubleshoot issues to maintain consistency and compliance.

Supply Chain & Quality Collaboration

• Partner with supply chain teams to manage material supply and resupply strategies.
• Collaborate on deviations, investigations, and corrective actions.
• Facilitate regular meetings and maintain documentation across internal and external teams.

Risk Management & Compliance

• Identify and mitigate supply chain risks.
• Maintain knowledge of internal and external quality systems.
• Participate in audits and due diligence activities as needed.

Qualifications

• Bachelor's degree in Chemistry, Life Sciences, or a related field.
• Minimum 5 years of experience managing CMOs and aseptic manufacturing, preferably in PET radiopharmaceuticals.
• Strong understanding of cGMP regulations; experience with IMP production and 21CFR Parts 211 & 212 preferred.
• Skilled in data analysis and performance reporting.
• Willingness to travel domestically (up to 30%) and occasionally internationally.
• Excellent communication, leadership, and cross-functional collaboration skills.

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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