Summary Statement
The Cleanroom Microbiologist reports directly to the Cell Processing Supervisor and Scientific Director. This person will be responsible for 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 determining 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 and 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.
- Performs data compilation, review and performs trend analysis on production processes and possible deviations when required.
- Assist with manufacturing of cell products, such Hematopoietic Stem Cells and T- cells
- Perform Flow cytometry testing ( CD34, Viability and B/T cells) as needed
- Work closely to QA department and participate in internal and external audits
- Supports all lab related tasks
- Provides support for projects by attending and participating in team meetings
- Participates in projects, task force jointly with production personnel in case the needs arise
- Other duties as assigned by manger
Knowledge, Skills and Experience
- 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, quality experience in 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 in order to author SOP's, Work Instructions, policies, forms and other documents
- Good interpersonal skills
- Self-Starter, 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.
- Specific gowning is required including gloves, hair and beard net and face cover, safety glasses with 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 are disinfectant, solvents and IPA (Isopropyl Alcohol 70% and 99%).
