Quality Control Senior Microbiologist II - United States
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- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as a QC Sr. Microbiologist II in our new commercial cell therapy production center.
- You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy.
- In this role you will be responsible for providing Quality Control Technical support to QC and Manufacturing.
- Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability)
- Establish user requirements for purchase, qualification of our company’s QC equipment and work with internal and external resources to maintain equipment in an optimal state
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as assigned.
- Bachelor's degree or advanced degree in Microbiology or related discipline
- Six to 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years’ experience with method and equipment validation within the biotechnology or pharmaceutical industry
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
- The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell therapy product
- Strong knowledge of Environmental Monitoring requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP)
- Experience in performing risk assessments
- Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation
- Extensive experience in conducting laboratory and environmental excursion investigations.
- Strong knowledge of Equipment IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Ability to think critically and demonstrate troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills
- Experience managing projects
- Experience drafting qualification/validation protocols and reports.
- Experience executing equipment and method qualifications independently.