Specialist, Quality Control, Microbiology

We are seeking a highly motivated individual to join us as a QC Specialist in our new commercial cell therapy production center located in Frederick, MD! You will report into the Associate Director Quality Control Microbiology and provide Quality Control support of commercial manufacturing of final drug product. You will also perform technical oversight of Quality Control methods and programs for cell therapy products. Are you ready to help bring life saving therapies to cancer patients in need?
Responsibilities (include but are not limited to):

• Conduct investigations regarding environmental monitoring (EM) action level excursions and out of specifications (OOS) results.
• Investigate and manage deviations related to microbiology procedures. Determine corrective/preventative actions (CAPA) and drive implementation.
• Generate trend reports on environmental monitoring and product release data. Frequently update management on trends. Implement corrective action plans when necessary.
• Perform the transfer, technical oversight and training of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
• Assist in the management of laboratory activities and provide technical direction to staff.
• 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.
• 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.
• Support the QC Microbiology and Aseptic Techniques Training programs.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree and 6+ years' of experience or Master's degree and 4 years of experience with a degree in Microbiology or related discipline.
• Minimum of 3+ years' of experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.
• Familiar in various microbiological techniques including rapid release methods, and environmental monitoring processes with reference to cell therapy product.
• Familiar in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes is preferred.
• Familiar with Environmental Monitoring requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
• Ability to gown for entry into Aseptic core and supporting areas.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
• 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
• 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.

#LI-TM1

Kite 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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