Title: Research Associate (Cell Bank Testing Associate)
Job location: Andover, MA
Job duration: 18 months
Work Schedule: Monday - Friday / First shift
Job Description:
- Conduct cell bank manufacturing operations as required.
- Follow and adhere to cGMP documentation practices, operational procedures, and compliance procedures.
- Perform cell bank distribution and shipping activities, as required.
- Adhere to safety procedures and guidelines by practicing and promoting safe work habits.
- Review and Archive GMP documents (SOPs, master batch records and campaign summary reports).
- Maintain cell banking facility and equipment in a constant state of operational and audit readiness.
- Collaborate with partners from diverse cross-functional lines to effectively resolve events and issues.
Minimum:
- High School Diploma or GED with 1-3 years of experience in a biotechnology manufacturing or laboratory environment.
- Preferred: Bachelor's degree in biology or related scientific discipline with 1-3 years of relevant experience
Must-Have:
- Knowledge of mammalian cell culture and/or microbial fermentation processes.
- Operational knowledge of computerized systems.
- Ability to follow Standard Operating Procedures and work under minimal supervision.
- Strong computer skills in Microsoft Office required, especially MS Word, MS Excel.
Nice-to-Have:
- Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting.
- Familiarity with business systems (e.g. Document Management Systems, LIMS, SAP, electronic Notebook, etc.)
- Experience in mammalian and microbial cell culture in a GMP setting with strong aseptic technique.
- Experience in cGMP compliance and regulatory compliance requirements as related to manufacture of biologics
Physical Needs:
- Must be able to gown into cleanroom environment and be standing for ~1-2 hours at a time.
- Must be able to manipulate screw-cap vials inside a BSC and aseptically fill at least 200 vials in a single setting.
- Must have practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site.
- Must be able to gracefully manage non-ideal situations under stress.
- Must have a change-agile growth mindset for navigating changing needs and priorities.