Cleanroom Microbiologist

About the role

The Cleanroom Microbiologist reports directly to the Cell Processing Supervisor and Scientific Director, planning, coordinating, and organizing the overall Quality Control activities of the Gift of Life Cell and Gene Therapy CNC and cleanrooms.

Responsibilities

• Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control.
• Perform environmental testing required for the cleanroom (ISO7 suites).
• Evaluate and interpret results of analytical/microbiological testing performed by third parties.
• Work with the QA department on cleanroom performance qualification.
• Develop an Environmental Monitoring program for GOL cleanrooms, establish sampling plans, and collect microbial samples as required.
• Trend results of monitoring and determine actions.
• Responsible for comprehensive recording of test results.
• Participate in all aspects of cleanroom out of specification, deviations, and contamination event investigations.
• Ensure that the necessary microbiology tests are done according to the test specification, test method, and working instruction to ensure on-time release for cell products.
• Complete all required documentation (including, but not limited to, batch records, log books, raw data (charts, graphs, scans, etc.), validation protocols, labels, and cGMP-related forms).
• Maintain a clean, organized laboratory environment including daily logs and sample tracking.
• Serve as author for qualification protocols and reports for GOL cleanrooms.
• Perform data compilation, review, and trend analysis on production processes and possible deviations when required.
• Assist with manufacturing of cell products, such as Hematopoietic Stem Cells and T-cells.
• Perform Flow cytometry testing (CD34, Viability, and B/T cells) as needed.
• Work closely with the QA department and participate in internal and external audits.
• Support all lab-related tasks.
• Provide support for projects by attending and participating in team meetings.
• Participate in projects and task forces jointly with production personnel as needed.
• Other duties as assigned by manager.

Requirements

• Experience with cGMP standards, SOPs, Environmental Health & Safety, and Quality requirements and applicable regulations; maintain awareness of industry best practices.
• Extensive experience with aseptic techniques.
• Experience in manufacturing and quality in the pharmaceutical industry, preferably cell therapy.
• Familiarity with standard concepts, practices, and procedures in the field of microbiology.
• Experience with aseptic gowning, environmental monitoring, sterility testing, and bacterial endotoxin testing.
• Experience with Flow Cytometry.
• Capacity to review and analyze data.
• Experience defending laboratory practices in regulatory audits.
• Excellent written communication skills to author SOPs, Work Instructions, policies, forms, and other documents.
• Good interpersonal skills.
• Self-starter and team player.
• Ability to work in a fast-paced controlled cleanroom environment up to 8 hours a day with additional overtime as required.
• Ability to work in a cleanroom with specific gowning requirements, including gloves, hair and beard net, face cover, safety glasses, and no makeup, jewelry, or piercings.
• Ability to use PPE (Personal Protective Equipment) and understand chemical hygiene, including labels and SDS (Safety Data Sheets). Common chemicals include disinfectant, solvents, and IPA (Isopropyl Alcohol 70% and 99%).