Associate Director, Quality Control
We're here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
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The Associate Director, Quality Control, will provide oversight for analytical methods of commercial and clinical manufacturing of final cell therapy drug product at Kite Pharma's Frederick, Maryland site. They will stage appropriate qualifications, as well as validation and transfer of bioanalytical methods. They will be responsible for in-process, final product testing, and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. This role will work with outside testing labs and other Kite sites for method transfers. Accountable for leading and managing the QC Analytical group, its people, projects and timelines.
Job Duties:
- Manage in-process, release, and stability testing in support of Commercial and Clinical Manufacturing
- Lead QC analytical team to sustain a scalable group to support multiple clinical programs.
- Establish user requirements for purchase, qualification of Kite's QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state.
- Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary.
- Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to OTL or other sites. Validation of methods will be phase appropriate.
- Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
- Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Develop, revise and review SOPs.
- Responsible for QC's training. Monitor the GMP systems currently in place to ensure compliance with documented policies
- Drive a culture of Operational Excellence in the group
- Conduct lab investigations, write deviations, and change controls
- Responsible for Data trending, control charts and metrics.
- Perform other duties as needed
Basic Qualifications:
- BS / BA and 8+ years of Quality Control experience or
- MS / MA and 6+ years of Quality Control experience or
- PhD and 2+ years of Quality Control experience
Preferred Qualifications:
- Advanced degree in molecular biologist or biochemistry preferred
- Candidate who is well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance.
- The ideal candidate has strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, UV and other applicable methods to the testing of cellular therapy products
- Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
- 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 CAPA and initiating change control
- 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
- Previous people leadership experience