Senior Supervisor, Quality Control Microbiology - 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 Microbiology Senior Supervisor 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 the day to day oversight of the QC Microbiology team and Sample Management team (Tuesday through Saturday shift)
- You will also be responsible for environmental monitoring program, raw material testing, final product testing and sample management program.
- Supervision of all QC Micro laboratory testing
- Supervision of sample receipt, retain storage and disposal
- Sustain environmental monitoring program for our company
- Management and optimization of the Aseptic gowning training and qualification program
- Management of QC Microbiology training program
- Work with QC raw materials team to establish specifications and testing process of raw materials.
- SME on investigations of sterility and environmental excursions
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of our company’s cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary
- Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release
- 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
- Provide updates at daily and weekly meetings
- 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
- Other duties as assigned
- Bachelor's degree or advanced degree in Microbiology or related discipline
- Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
- A minimum of 7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 3 years’ experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry
- The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product
- Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, on an as-needed
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Quality Control, GMPs, microbiological method development and validation
- Strong knowledge of GMP, SOPs and quality control processes
- Strong data integrity knowledge and practices.
- Identifying, writing evaluating and closing OOS’s and investigations
- Strong knowledge of aseptic manufacturing and EM processes
- Equipment and utility IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.