Title: Research Associate

Location: Chesterfield, MO

Duration: 18+ months

Job Description:

• 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 products.
• 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 to identify and solve moderately complex problems.

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.

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 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.