Manufacturing Associate I or II (CMC) – GMP

Manufacturing Associate I or II (CMC) – GMP

(all genders welcome)

Job Overview

The primary purpose of the Manufacturing Associate II is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing under supervision.

Overall Responsibilities

  • Performs cell growth and manipulation procedures such as cell enrichment, cell evaluation and sorting, cell culture, cellular product cryopreservation, cell product thaw/wash with minimal supervision.
  • Familiar with and performs calculations to determine cell viability, dilutions, and cell concentrations.
  • Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.
  • Documents deviations and events and notifies supervisor and quality management personnel in timely manner and assists in investigation of cause and any required corrective actions.
  • Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers.
  • Performs procedures and maintains accurate documentation in compliance with SOPs and appropriate federal and local regulations.
  • Follows procedures and policies implemented by Principal Investigator and adheres to all defined process and documentation requirements.
  • Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
  • Performs routine equipment maintenance and troubleshooting.
  • Coordinates supply inventory.

Qualifications and Requirements

  • To be considered for this position, applicants must meet the following requirements: 
    • Bachelor’s Degree in Biology, Biochemistry, Biotechnology or other related field.
    • Three (3) to Five (5) years of cell therapy manufacturing experience.
    • Demonstrated cell culture and aseptic processing experience.
    • Basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique, cell counting and managing reagents.
    • Experience in molecular, cellular, immunological techniques.
    • Knowledge of current cGMP.
    • Excellent general lab skills.
    • Thorough understanding of process validation.

Other Skills and Abilities

  • Write study plans, reports, BRs, WI, and SOPs as directed.
  • Ability to communicate effectively both orally and written and the ability to present effectively to small groups.
  • Good problem solving and process improvement methodologies.
  • Ability to execute complex lab studies and provide sound interpretation of results.
  • Ability to write, review and edit technical documents.
  • Ability to perform in cross-functional teams to achieve objectives within require time frames.

Physical Demands and Work Environment

    • Lifting up to 40 lbs.
    • Standing/sitting for long periods of time.
    • Indoors but in laboratory setting.
    • Potential loud noise
    • Vision to perform experiments and analyze results.