Look for someone who's having good experience in Radiochemistry.

Job Role : GMP Manufacturing Technician

Location : Watertown, MA 02472

Fulltime Role

Reporting : Associate Director, Clinical Manufacturing

Description :

We are seeking an experienced GMP Manufacturing Technician , advancing personalized medicine and radiochemistry.

Illustrative Breadth of Responsibilities :

• Directly contributing to the production of the next generation of radiotherapeutics for Mariana's clinical trial programs
• Planning and executing routine production, packaging, and shipping of radiochemistry.
• Following aseptic techniques for manufacturing processes, line clearances, and sterility activities
• Participating in the process validation, tech transfers, equipment qualification and the production of all radiochemistry drug product for supporting Mariana'

s clinical trial programs

• Monitoring of the production-related equipment used to ensure proper function and report any maintenance needs to plant engineering.
• Adhering to all applicable procedures, cGLP, cGMPs, cGDPs, SOPs, Radiation Safety, Mariana policies and QMS and any other quality or regulatory requirements
• Producing and properly recording data per SOPs and cGMP guidelines, to support lot release and CoA generation while closely working with Quality Assurance team.
• Performing various activities in a clean room environment
• With the QA department, supporting all investigations, manufacturing deviations, OOS, CAPA and customer complaints
• Performing required package testing activities / DOT requirements for release of radiopharmaceuticals for delivery
• Maintaining manufacturing supplies and inventory as appropriate
• Contributing to overall CMC strategy development and capacity planning

Requirements / Skills :

Bachelor's Degree, Associate Degree, or 5 years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry.

Experience working with radiochemistry is preferred

• Experience working in a controlled or cleanroom environment preferred
• General knowledge and experience performing aseptic techniques
• GMP and cGMP experience, as well as knowledge of GMP and cGMP regulations, and guidelines
• Technically oriented and able to troubleshoot basic mechanical equipment issues and interface with varied software programs
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements
• Good understanding of the radiation safety regulations and guidelines is preferred
• General understanding of chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND, IMPD, MAA, BLA, NDA, ANDA, or other regulatory pathways.
• Comfortable handling radioactivity and following proper ALARA (As Low As Reasonably Achievable) technique
• Communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships

Last updated : 2024-05-21