Sr. Director - Head of Global Raw Materials & ReagentsUnited States - California - Santa MonicaQualityRegular
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. Join us in our mission!
Kite is seeking a highly motivated individual and experienced leader to join Kite as a Senior Director, Global Quality Control, to set up and strategically manage our Global Raw Materials and Reagents Center of Excellence.
Reporting to the Global Quality Control Head in Santa Monica, CA, in this role you will continue to build and mature Kite’s Raw Materials and Reagents Center of Excellence with focused expertise in bioanalytical and micro method development and including management of the Logistics, Testing and Technical Excellence groups. You will develop Kite’s strategy to position the company as a leader in this arena, and in particular for Cell Therapy, guiding, educating and influencing the Industry and Regulators.
Additionally, you will collaborate closely with Global Supply Chain and our network of Kite manufacturing sites and QC laboratories around the globe to provide strategic direction for the Global Raw Materials and Reagents program, qualification and release of materials for use in both the manufacturing process and Raw Materials and Reagents QC analytical release and stability methods. As importantly, you will comprehensively understand and educate regarding technology capabilities and detection, advance introduction of innovative approaches and/ or appropriate methodologies to position Kite as the leader in this field, rapidly respond to and investigate issues related to our Raw Materials and Reagents program, and publish ‘position papers’ to guide the Industry and scientific community.
Responsibilities include (but are not limited to):
- Develop ‘forward thinking’ strategy and vision for a Global Raw Materials and Reagents Center of Excellence program.
- Strong knowledge and expertise in bioanalytical and micro method development, validation and method transfer.
- Manage Logistics, Testing and Technical Excellence groups to ensure timely testing, qualification and release of Raw Materials and Reagents for use in manufacturing processes (Commercial and Clinical) and QC analytical release and stability methods for patient lot release.
- Establish user requirements for purchase, qualification of Kite’s QC equipment. Work with internal and external resources to maintain equipment in an optimal state.
- Develop appropriate and comprehensive QC Raw Materials and Reagents Testing, Techniques and Training programs.
- Manage method transfers to/ from contract testing labs and Kite facilities as appropriate.
- Responsible for personnel recruitment, development and retention.
- Responsible for raw materials and reagents OOS, deviations and CAPAs.
- Draft and review appropriate sections of BLA, IND.
- Participate in PAI, defend regulatory audits and draft response.
- Prepare dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
- 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.
- Liaise with other departments to ensure business continuity including, quality, manufacturing, supply chain, warehousing, and PD
- Perform other duties as required.
- Advanced Scientific Degree (i.e. MD, PharmD, PhD) with 12+ years of Quality Control experience in the biotech and/or pharmaceutical industry OR
- Master's Degree with 12+ years of Quality Control experience in the biotech and/or pharmaceutical industry OR
- Bachelor's Degree with 14+ years of Quality Control experience in the biotech and/or pharmaceutical industry OR
- High School Degree with 18+ years of Quality Control experience in the biotech and/or pharmaceutical industry
- Minimum of 5 years Quality/Analytical Lab Management experience
- Well versed in various analytical techniques such as HPLC, MS, FACS, ELISAs, PCR, FTIR, Gel/ Western Blot, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of Raw Materials and Reagents
- Identifying, writing evaluating and closing OOS’s and investigations
- Equipment and utility IQ/OQ/PQ/PV
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Strong knowledge of technical writing for BLA, IND.
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
- Ability to write up technical assessments and that use modern risk management methodology.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Ability to think critically and demonstrate troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills