Research Assistant

3 days ago


Andover, United States Integrated Resources, Inc ( IRI ) Full time

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.


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