GMP Manufacturing Technician

3 weeks ago

Watertown, United States Anansys Staffing LLC Full time
Job DescriptionJob Description

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

Job Role: GMP Manufacturing TechnicianLocation: Watertown, MA 02472Fulltime RoleReporting: 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
  • Maintaining and performing routine environmental monitoring procedures per SOPs.
  • 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

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