For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
We are seeking a highly motivated individual to join us as a Senior Manager, Quality Control. Reporting to the Site Quality Head in Oceanside, CA, you will build the QC Analytical team and implement and manage Kite Pharma Quality Control Analytical in Oceanside, CA. You will collaborate closely with other Kite manufacturing sites around the globe and manage tech transfer and validation of QC Analytical assays.
In this role, you will provide oversight for analytical methods of commercial and clinical stage manufacturing of viral vector drug substance. You will also be responsible for phase appropriate validation of bioanalytical methods oversight and management, in-process, final product testing, and stability testing, upkeep and maintenance of QC instrumentation and lab in GMP compliance, work with outside testing labs and other Kite sites for method transfers and be accountable for managing the QC Analytical group, its people, projects and timelines.
Additional Responsibilities (include but are not limited to):
- Manage the transfer and validation of analytical methods to Oceanside, CA, QC laboratories and for clinical stage product from Analytical Development. Validation of methods will be phase appropriate.
- Establish user requirements for purchase, qualification of Kites 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. Provide updates at daily and weekly meetings.
- Partner with IT and QE to implement LIMS at Oceanside, CA
- Lead QC analytical team to sustain a scalable group to support multiple clinical programs.
- Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.
- Lead regulatory inspections and Interact with Regulatory agencies and participate in Inspections.
- Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process, and drug substance testing. Develop, revise and review SOPs.
- Responsible for QCs training and monitoring the GMP systems currently in place to ensure compliance with documented policies.
- Manage and conduct lab investigations, write deviations, and own change controls.
- Responsible for data trending, control charts and metrics.
- Up to 10% domestic travel
- Perform duties as needed
- 8+ years of experience with BS degree in Molecular Biology, Biochemistry, Biology or a related scientific discipline
- 6+ years of experience with MS degree in Molecular Biology, Biochemistry, Biology or a related scientific discipline
- Candidate should be well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance.
- The ideal candidate has a strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, cell-based assay, and other applicable methods to the testing of viral vector and 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.
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 .
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.