Quality Control Microbiology Supervisor - Cell Therapy

Quality Control Microbiology Supervisor - Cell Therapy
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area (West Hills, CA), and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company's next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT's lead program, a bispecific "OR-gate" CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far.
ImmPACT Bio provides a generous rewards package, with competitive compensation and health benefits, with career progression benefits as part of a rapidly growing multi-platform company.
ImmPACT-Bio is seeking a Quality Control Microbiology Supervisor to support our new T-Cell Therapy GMP clinical manufacturing facility in West Hills, CA.
You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Director of Quality Control. In this role you will be responsible for the day-to-day oversight of the QC Microbiology main functions; Environmental Monitoring (EM)/ Utilities Monitoring (UM) and Microbiology Testing. You will be responsible for the environmental monitoring program, utility testing, incoming testing of media and final product microbiological testing, as needed.
Primary Responsibilities:

• Supervision of all QC Micro laboratory testing
• Maintain environmental monitoring program for the site and on-time release of product lots to patients
• Management of the aseptic gowning training and qualification program
• Support internal and external audits
• Maintain and support of QC Microbiology Associate training
• Assemble reports on findings from cGMP facility/utilities, as needed. Implement corrective action plans when necessary and frequently update management on environmental trends
• Complete routine record review of test data and related documents for in-process and routine environmental monitoring testing, drug product release. Generation of CoAs for product release
• Develop, revise and review SOPs, qualification/validation protocols and reports
• Conduct EM excursions investigations as Subject Matter Expert (SME).
• Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures and processes
• 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
• Conduct performance management of direct reports and have regular development discussions

Qualifications:

• Master's Degree and 3+ years of Microbiology experience OR Bachelor's Degree and 5+ years of Microbiology experience OR High School Degree and 9+ years of Microbiology experience
• Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
• Minimum of 5 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.
• Minimum of 3 years' experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry
• Experience in the application of microbiological techniques such as air monitoring, surface monitoring, genus and species identification of various microbes, endotoxin testing and sterility testing of final product.
• Candidate should be well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to Cell Therapy product
• 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
• Ability to be flexible with schedule, and work overtime as needed
• Working knowledge of SOP writing and SOP change request is a plus
• Able to follow instructions and SOPs precisely and able to make/keep accurate documentation
• Detail-oriented with good written and verbal communication skills
• Good organizational and planning skills, and an ability to work efficiently
• Able to seek and accept input from more senior team members for the performance of assignments as needed
• Team player with good interpersonal skills

ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for cancer patients who have exhausted their treatment options. The company's logic-gate-based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio's technologies are specifically designed to prevent antigen escape, prevent 'on-target - off-tumor' toxicities, and overcome the immunosuppressive tumor microenvironment.