Research Associate I
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.