Job Title: Mammalian Cell Processing Specialist

Job Description

The Mammalian Cell Processing Specialist is responsible for executing detailed and precise cell processing tasks in a flexible and sometimes unpredictable work schedule. This role requires specialized training in GMP grade conditions, as well as proficiency in both manual and automated processing. The candidate must possess knowledge of cell culture and flow cytometry and adhere to GMP/GDP documentation guidelines.

Responsibilities

• Adhere to GMP guidelines in cleanroom (ISO7) environment.
• Perform flow cytometry to assess cell viability and count.
• Perform isolation of HSCs, NK, and T-cells.
• Conduct calculations during processing to assess product yields.
• Utilize aseptic techniques while performing cell processing procedures.
• Investigate and resolve problems with procedures or processes.
• Execute validation processes on new instruments and equipment.
• Perform sterility and environmental monitoring testing with QC specialist.
• Collaborate closely with QC specialist and QA department.
• Ensure documentation is accurate, complete, comprehensive, and maintained.
• Collect and label required laboratory samples and maintain accurate and complete result reports, processing worksheets, and cryopreservation records.
• Perform quality control and preventative maintenance on instruments and equipment and maintain complete and accurate records.
• Practice proper safety techniques and report any unsafe conditions.
• Perform other duties and procedures as assigned.

Essential Skills

• Cell culture
• Cell therapy
• Flow cytometry
• Mammalian Cell Culture
• ELISA
• Research & Development
• Assay
• Cleanroom operations
• Cell Isolation
• Cell Biology
• HEK, CHO, MSC

Additional Skills & Qualifications

• Experience in cGMP requirements highly preferred.
• Experience in flow cytometry assays and interpretations preferred (Cytoflex).
• Knowledge of sterile techniques required.
• Knowledge of the use of liquid nitrogen for cryogenic environments.
• Experience with microbiological testing preferred.
• Experience with CliniMACS Prodigy preferred.

Work Environment

The work environment is an ISO 7 cleanroom, requiring adherence to GMP guidelines. It is a family-oriented, growing team setting, offering opportunities to collaborate closely with QC specialists and the QA department.