Cell Bank Testing Associate

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: