Eckert & Ziegler Radiopharma Inc
Lead Radiochemist
Eckert & Ziegler Radiopharma Inc, Wilmington, Massachusetts, United States, 01887
Job Description
Job Description
Lead Radiochemist Location:
Wilmington, MA (on-site role only) Employment Type:
Full-time 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 clinical-stage manufacturing site in Wilmington, MA that supports: Yttrium-90 (Y-90) Production Lutetium-177 (Lu-177) 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
Lead Radiochemist
to join our team in Wilmington, MA. This role is focused on
supporting radiolabeling activities
in our CMO operations. The Radiochemist will work hands-on in GMP radiochemistry laboratories to execute client projects, support technical transfers, and contribute to process validation. Key Responsibilities Support radiolabeling campaigns for client projects, including small molecules, peptides, and biologics. 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
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
, 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
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. Compensation & Benefits Eligible for annual bonus. Comprehensive benefits package including medical, dental, vision, life insurance, retirement savings plan, and paid time off. Work Schedule & Conditions Primarily early morning day shift. Occasional off-hours or weekend work required for production campaigns.
Job Description
Lead Radiochemist Location:
Wilmington, MA (on-site role only) Employment Type:
Full-time 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 clinical-stage manufacturing site in Wilmington, MA that supports: Yttrium-90 (Y-90) Production Lutetium-177 (Lu-177) 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
Lead Radiochemist
to join our team in Wilmington, MA. This role is focused on
supporting radiolabeling activities
in our CMO operations. The Radiochemist will work hands-on in GMP radiochemistry laboratories to execute client projects, support technical transfers, and contribute to process validation. Key Responsibilities Support radiolabeling campaigns for client projects, including small molecules, peptides, and biologics. 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
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
, 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
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. Compensation & Benefits Eligible for annual bonus. Comprehensive benefits package including medical, dental, vision, life insurance, retirement savings plan, and paid time off. Work Schedule & Conditions Primarily early morning day shift. Occasional off-hours or weekend work required for production campaigns.