Cell Processing Associate (Cell Culture, Sterile Processing, Clean Room, ISO, cGMP)
Leading Biopharmaceutical company hiring multiple Cell Processing/ Manufacturing Associates for 5 advancement job opportunities; the new hires will utilize their knowledge of Cell Culture, Aseptic Processing, ISO, cGMP and GDP, to secure long-term full time employment within the growing Biopharmaceutical field! We are looking for skills, committed, positive, dynamic individuals looking for a long-term growth potential!!
Job Type: Full-time
- Manufacture clinical grade cellular therapeutic products to supply the Clinical Program:
- Execute/Implement batch records in ISO 7 & 8 Clean Room environments.
- Observe, practice, and promote all aspects of the GMP & GDP requirements.
- Complete and maintain Aseptic Processing and Sterile Gowning qualifications.
- Communicate with Quality Control (QC) to ensure proper hand-off of process samples.
- Maintain laboratory and equipment for cleanliness and compliance.
- Complete room activity, maintenance, cleaning, and equipment usage logs.
- Run daily calibration checks on equipment where appropriate, and escalate deviations.
- Perform daily, weekly, and extended sterilization of lab and equipment.
- Ensure sufficient laboratory supplies for daily laboratory operations.
- Assists with development of Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Development into Manufacturing Operations
- Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
- Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
- Reports and initiates non-conformances, and participates in follow up investigation when necessary.
- B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline
- Minimum 1-3+ years of relevant experience in a laboratory or Cell Culture Processing environment.
- Minimum 1-3+ years hands-on experience with Cell Culture, Aseptic Processing, Clean Room, Sterile Gowning ISO, GMP, GDP
- Proficient in Microsoft Office Suite and basic computer applications
- Experience working in an Aseptic or Sterile Processing Environment, cGMP gowning, de-gowning environment
- Experience in cGMP cell culture manufacturing, and cell therapy preferred.
- Aseptic processing in ISO biosafety cabinets.
- Cell expansion using incubators and single use bioreactors.
- Cell washing, cell separation techniques and use of automated equipment.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Experience with SAP, Trackwise, etc. desired
Keywords: Cell Culture, Aseptic Processing, Clean Room, Sterile Gowning ISO, GMP, GDP, Manufacturing technician, production technician, biological manufacturing, bioprocessing, biotechnology manufacturing, biotechnology, cGMP, gowning, de-gowning, cell sorting, clinical, sterilization.
FOR IMMEDIATE CONSIDERATION, please:
- Send email to [Click Here to Email Your Resumé]
- Put 'Cell Processing Associate' in the subject line
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.