Cell Bank Testing Associate

4 days ago

Andover MA United States Joulé Full time

Job Title: Cell Bank Testing Associate
Location: Andover, MA
Type: Contract, Potential for extension or conversion to permanent

Responsibilities Coordinate cell bank/bulk harvest testing, including creation of specifications, submission of samples to testing laboratory and review and approval of results.
Maintain all related data and records in compliance with cGMPs and quality procedures. Collaborate with team members and partner functions (e.g. Quality Assurance) to ensure all cell bank testing-related quality and compliance requirements are met.
Author technical documents and standard operating procedures (SOPs) Pay attention to detail, strictly adhere to standard operating procedures, and use knowledge to advance projects under rapidly shifting priorities and timelines.
Support product investigations and new method evaluation(s) as needed.



Requirements Associate Degree or Bachelor's degree in biology or related scientific discipline with 0 - 3 years of relevant experience.
Experience in a biologics manufacturing or laboratory environment.
Good understanding of mammalian/microbial cell culture techniques
Good documentation skills with high attention to detail and strong organizational skills
Familiarity with cGMP requirements
Excellent oral and written communication skills


Nice-to-Have Experience with cell banking-related activities
Knowledge and practical application of microbiological/viral testing methods and molecular biology techniques
Experience with laboratory information management systems or documentation management systems
Technical writing experience for documents such as SOPs and technical documents


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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