Associate Director, QC Analytical Operation

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 17, 2020
Ref
R0015121
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite is seeking a highly-motivated individual with experience in QC clinical lot release testing program and QC metrics management to work on innovative T cell therapy for cancer treatment. The Associate Director, QC Analytical Operation will provide leadership to the 7+ QC team responsible for lot release, technical support, laboratory investigations, CAPA/deviations, post-qualification method improvement and regulatory filing support for Kite's clinical manufacturing sites producing viral vectors, autologous and allogenic T cell therapy products.

Key responsibilities:
  • Lead the operational team to maintain first time right metrics of routine lot release testing and the technical team to provide technical expertise and guidance to the quality organization by supporting or managing deviations, investigations, changes, risk assessments and CAPAs.
  • Develop and support deployment of quality requirements for technologies and/or modalities which require improved analytical methodology with technical acumen
  • Lead the technical team in the design and execution of technical studies, method qualification and validation
  • Provide leadership and guidance in incoming method transfers from Analytical Development group and outgoing method transfer to QC commercial sites and/or external business partners
  • Establish and collect analytical data to serve as metrics, control charts and method trending
  • In collaboration with Global QC network to evaluate and implement continuous improvement initiatives and method life-cycle management
  • Promote a culture of quality mind-set and operational excellence.

Qualifications:
  • BS/BA and 10 years, MS/MA and 8 years OR Ph.D and 2 years of relevant experience
  • Academic degrees in Molecular Cell Biology, Immunology, Virology, Biotechnology or equivalent with managing analytical QC laboratory experience
  • Expertise with cGMP manufacturing knowledge, and FDA/EMA regulatory requirements for clinical biopharmaceuticals, preferably cell therapy products.
  • Mastery of scientific viral vectors and T-cell therapy principles
  • Practical experience in clinical GMP laboratory operations with phase appropriate approach
  • Demonstrated experience with creating and implementing effective cGMP quality systems, inclusive of writing SOPs; product CoA release activities, inclusive of batch record and QC record review; facilitating and closing MRBs/investigations, deviations and associated CAPA
  • In depth understanding and application of industry standards and cGMP/international regulations and guidelines.

Skills:
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Proven ability to lead subordinate staff and work with senior level leaders
  • The desire and ability to work in a fast-paced environment
  • Strong collaboration, teamwork, organizational skills with attention to details
  • Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders

Experience:
  • Must have at least 5 years of managing pharmaceutical QC labs for product release, method transfer and/or assay development experience
  • Pharmaceutical products GMP experience is a must
  • Cell culture or aseptic processing experience is a plus
  • Previous experience with cell therapy products is a plus
  • Equipment qualification knowledge in a cGMP environment (IQ, OQ, PQ) is preferred; analytical method qualification, validation and transfer experience is a plus
  • Experience with LIMS and automation is a plus
  • Proven track record of leading and managing cross- functional teams
  • Knowledge of data management tools and statistical controls


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.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.