4 gmp manufacturing technician Jobs in watertown, ma
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GMP Manufacturing Technician
$51k-69k (estimate)
Full Time
3 Days Ago
Anansys Staffing is Hiring a GMP Manufacturing Technician Near Watertown, MA
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 ManufacturingDescriptionWe are seeking an experienced GMP Manufacturing Technician, advancing personalized medicine and radiochemistry.
Illustrative Breadth Of Responsibilities
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
- 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
Job Summary
JOB TYPE
Full Time
SALARY
$51k-69k (estimate)
POST DATE
05/28/2024
EXPIRATION DATE
06/21/2024
WEBSITE
anansysstaffing.com
HEADQUARTERS
Fairfield, WA
SIZE
<25
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