AD, Quality Control Microbiology

Descripción del trabajo

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.

Kite is seeking a highly motivated individual to join us as an Associate Director, Quality Control Microbiology. You will work with the Quality Control team 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.

Responsibilities: 

The Associate Director of QC Microbiology will provide strategic and operational direction for the commercial microbiology group and has the overall responsibility for the planning, coordination, and supervision of technical and operational activities in the microbiology laboratory.

• Oversees execution of testing including routine lot related analysis, environmental monitoring and raw material testing
• Oversight of routine record review of test data and related documents for in-process testing, drug substance and drug product release.
• Generation and approval of certificates of analysis for product release.
• Accountable for the management of the Environmental Monitoring (EM) program including monitoring and trending data.
• Responsible for the QC Microbiology and Aseptic Techniques Training programs. 
• Ensures training of the microbiology group is complete and meets requirements.
• Ensures adherence to department, site and corporate SOPs and other regulatory requirements.
• Lead investigations regarding out of specifications (OOS) results and EM excursions. Address and manage deviations related to microbiology/EM procedures. Evaluates and determines corrective actions.
• Evaluate and implement continuous improvement initiatives.
• Assist in the preparation of dossiers and data packages for interactions between Kite and regulatory agencies.  
• Supports and interacts with Health authorities from regulatory agencies and participate in regulatory inspections.
• Develop, revise and review SOPs, qualification/validation protocols and reports
• Effectively communicates with other departments and/or internal groups.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Basic Qualifications:

• Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility OR
• Master’s Degree and 8+ years’ experience in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility OR
• Bachelor’s Degree and 10+ years’ experience in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility OR
• High School Degree and 14+ years’ experience in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility

Preferred Qualifications:

• Strong knowledge of Environmental Monitoring requirements and tests (viable and non-viable),  Aseptic Process Validation (APV), USP/EP Microbiological methods and microbial identification.
• 5 years supervisory experience.
• Experience in aseptic techniques, sterile gowning procedures and clean room operations.
• Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
• Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls
• Ability to effectively negotiate and build collaboration amongst individuals
• Demonstrated ability to develop, coach, and mentor key employees
• 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

Does this sound like you? If so, apply today!