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Quality Control Microbiology - Manager, Quality Control

United States - California - San DiegoQualityRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

We are seeking a highly motivated individual to join us as a Manager, Quality Control in our new viral vector manufacturing facility located in Oceanside, CA. 

Responsibilities

  • Oversees execution of final product release testing including EM, raw material/growth promotion testing and water testing.
  • Complete routine record review and approval of test data and related documents for inprocess testing, utility monitoring and drug substance/drug product release. i.e. lot report and CofA.
  • Accountable for the management of the EM programs including monitoring and trending data in LIMS.
  • Establish user requirements for purchase, qualification of Kite’s QC microbiology equipment.
  • Work with internal and external resources to maintain equipment in an optimal and compliant state.
  • Responsible for the QC Microbiology and Aseptic Techniques Training programs.
  • Manage and conduct lab investigations regarding out of specifications (OOS) results and EM excursions. Address and manage agile records related to microbiology operations/EM program for timely closure.
  • Author and own Agile records including deviation, CAPA, EV, and change controls.
  • Evaluate and implement continuous improvement initiatives.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Ensures adherence to department, site and corporate SOPs and other regulatory requirements for lab readiness for audit.
  • Interact with inspectors as Microbiology SME and participate in internal, corporate and QP inspections.
  • Assist in the preparation of data packages for interactions between Kite and regulatory agencies.
  • Responsible for ensuring QC Microbiology training is complete in timely manner to meet business requirements and ensure compliance with documented policies/SOP.
  • Responsible for data trending, control charts and metrics for final product testing as well as routine micro operations.
  • Support cross site projects as needed including tech transfer activities.
  • Up to 10% domestic travel.

Basic Qualifications:

Master’s Degree and 4+ years’ experience in the application of microbiological techniques

OR

Bachelor’s Degree and 6+ years’ experience in the application of microbiological techniques

OR

High School Degree and 10+ years’ experience in the application of microbiological techniques

Preferred Qualifications:

  • Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
  • Minimum of 7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.
  • Minimum of 2 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, water testing, 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

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