Cell Bank Testing Associate

Job Description

Job Summary:

• This role is part of Client’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.

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.

Education and Experience:

• High School Diploma or GED with 1-3 years of experience in a biotechnology manufacturing or laboratory environment.
• Bachelor’s degree in biology or related scientific discipline with 1-3 years of relevant experience.

Must-Have Technical Requirements:

• 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 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 client 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.

Interview:

• First round: Phone screening.
• Second round: Teams Interview.