Cell Bank Testing Associate

3 weeks ago

Andover, United States LanceSoft Full time

Job Description: POSITION SUMMARY
• This role is part of ***'s Bioprocess Research & Development Cell Banking team responsible for the manufacturing and testing of GMP cell banks used to produce clinical and commercial biopharmaceutical product.

POSITION RESPONSIBILITIES
• 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.
• Understand scientific principles in order to identify and solve moderately complex problems.
• Make sound and compliant decisions with minimal input that may require choosing from limited options.
• Think critically and facilitate the drive towards continuous improvement.
• Effectively manage own time and balance workload priorities.

ORGANIZATIONAL RELATIONSHIPS
• Cell Bank testing team
• *** QA
• PharmSci Cell Bank team
• *** shipping and logistics teams
• *** calibration and validation colleagues

EDUCATION AND EXPERIENCE
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

TECHNICAL SKILLS REQUIREMENTS
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.
• Understanding of scientific principles, ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Strong interpersonal, teamwork, and collaboration skills with the ability to work in a complex, multi-discipline organization under minimal supervision.
• Excellent oral and written communication skills.
• 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 POSITION REQUIREMENTS
• 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.

Schedule: Monday - Friday / First shift / Possible off shift hours (not OT)

Interview: First round: Phone screening
Second round: Teams Interview
Position Comments visible to Supplier:

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