Cell Bank Testing Associate

Cell Bank Testing Associate

Summary:

This role is part of Pfizer’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.

Minimum Qualifications:

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

Preferred Qualifications:

• Bachelor's degree in biology or related scientific discipline with a minimum of 1-3 years of relevant experience preferred
• 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 related to biologics manufacturing.

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.

Location:

• This is a fully onsite role in Chesterfield, MO

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.