Summary:

The Technical Associate, Cell Banking role is part of a biotechnology manufacturing team focused on cGMP microbial and mammalian cell bank preparation, storage, inventory management, and distribution to end users. The focus of this position involves conducting operations according to approved SOPs and batch records, maintaining and operating associated equipment, revising SOPs and batch records, storing and managing cell bank inventory, and coordinating cell bank distribution as needed. The role will act as part of a team of scientists and technicians focused on manufacturing and managing mammalian and microbial cGMP cell banks for production of vaccines and protein biotherapeutics. This individual in this role will perform cell culture, vial filling and cryopreservation activities required for cGMP cell bank manufacturing, as well as support inventory management, and shipping activities. They will also support equipment and facility qualification and maintenance activities as needed.

Job Responsibilities:

Conduct cell bank manufacturing operations. Adhere to cGMP documentation practices, operational procedures, and compliance procedures. Coordinate cell bank distribution and shipping activities, which may include international shipments. Follow safety procedures and guidelines by practicing and promoting safe work habits. Author and revise GMP documents (e.g., procedures, master batch records). 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.

Skills/Knowledge/Physical Demands:

Required:

Follow Standard Operating Procedures and work under minimal supervision. Possess understanding of scientific principles, ability to think critically, and demonstrate troubleshooting and problem-solving skills. Demonstrate excellent oral and written communication skills. Demonstrate strong interpersonal, teamwork, and collaboration skills with the ability to work in a complex, multi-discipline organization under minimal supervision. Have practical knowledge of computers and software (e.g., Microsoft Office Word, and Excel). Be able to gown into a cleanroom environment and stand for ~1-2 hours at a time. Be able to manipulate screw-cap vials inside a biosafety cabinet and aseptically fill > 200 vials in a single setting. Observe all safety policies and always use required personal protective equipment. Possess a change-agile growth mindset for navigating changing needs and priorities.

Preferred:

Familiarity with business systems for management of documents, samples, inventory, compliance, etc. (e.g., GDMS, LIMS, SAP, QMS). Experience with mammalian and microbial cell culturing with demonstrated aseptic technique. Familiarity with cGMP compliance and regulatory requirements in the pharmaceutical field.

Education/Experience:

Minimum:

High School Diploma or GED; 0-2 years of experience in a biotechnology manufacturing or laboratory environment.

Preferred:

Bachelor's degree in science related field. Prior experience in a biological pilot plant, or cGMP pharmaceutical manufacturing setting. Pay Rate Range 21 - 26 USD hourly Additional Notes Please note that 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. Benefits Information Comprehensive Benefits Package available based on eligibility Medical, Dental, Vision Short-Term Disability (STD) Long-Term Disability (LTD) Supplemental and Voluntary Life Insurance 401(K) Commuter Benefit Program