Contract Radiochemist (Radiolabeling Support)
Job Description
Job Description
Contract Radiochemist (Radiolabeling Support)
Contract Term: 3 months (option to extend)
Location: Wilmington, MA (on-site role only)
About Eckert & Ziegler Radiopharma, Inc.
Eckert & Ziegler Radiopharma, Inc. (EZRI) is a U.S.-based subsidiary of Eckert & Ziegler AG, a global leader in isotope technology and radiopharmaceutical manufacturing. EZRI operates a manufacturing site in Wilmington, MA that supports:
- Yttrium-90 (Y-90) production
- Analytical Testing Devices
- Contract manufacturing (CMO) services for radiolabeled pharmaceuticals
Our mission is to enable partners in biotech and pharma to accelerate radiopharmaceutical innovation while ensuring the highest standards of GMP compliance, safety, and quality.
Position Summary
We are seeking a Contract Radiochemist to support radiolabeling activities within our CMO operations. The candidate will work hands-on in the lab to execute client radiolabeling projects, contribute to technical transfers, and support process validation under GMP conditions.
Key Responsibilities
- Support radiolabeling campaigns for client projects.
- Participate in technical transfer and process validation activities for new projects.
- Assist in evaluating technical feasibility of proposals and provide input to project teams.
- Prepare GMP suites, materials, and documentation required for radiolabeling runs.
- Apply USP <825> and 21 CFR 211 requirements in daily radiochemistry operations.
- Collaborate with QA/QC, vendors, and project management to ensure readiness and timely execution.
- Maintain accurate GMP documentation (batch records, reports, change controls).
- Handle and dispose of radioactive materials safely and in compliance with radiation safety protocols.
Key Performance Expectations
- Radiolabeling projects executed in compliance with client and regulatory requirements.
- Validation and production runs supported to meet quality specifications.
- Effective collaboration with operations, QA, and project teams to achieve production timelines.
- Consistent adherence to GMP, USP <825>, and radiation safety standards.
Required Skills & Qualifications
- Direct radiolabeling experience is required.
- BS in Chemistry (8+ years), MS (5+ years), or PhD (3+ years) with hands-on radiochemistry experience (PET IND radiosynthesis preferred).
- Strong working knowledge of USP <825> and cGMP (21 CFR 211).
- Proficiency with hot cell manipulators and routine radiochemistry equipment.
- Demonstrated experience in GMP radiochemistry production environments.
- Strong troubleshooting, organizational, and communication skills.
- Ability to work on-site, adapt to project needs, and collaborate across functions.
- Must be able to stand for extended periods and perform routine demands of radiochemistry work.
Work Schedule & Conditions
- Primarily early morning day shift.
- Occasional off-hours production campaigns.
- On-site only; remote work is not available.