Director of Global Manufacturing Sciences and Technology (MSAT) Validation

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 16, 2020
Ref
R0012384
Required Education
Masters Degree/MBA
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

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment, and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day - discoveries that include our own capabilities and our individual potential.

We are seeking a highly motivated leader to join as a Director of Global Manufacturing Sciences and Technology (MSAT) Validation. This individual will provide strategic leadership for novel technology qualification, product comparability, process validation and GMP manufacturing for Kite's engineered autologous T cell therapy products and viral vector programs. Additionally, the Director will define technical requirements and lead comparability and process validation project plans and protocols, sampling plans, production procedures, and process development reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, equipment qualification, and validation to meet regulatory requirements. Lastly, the Incumbent will work with the Process Design, Manufacturing and Quality teams to implement cell therapy processes to multiple sites, establish novel technology and equipment qualification strategies and lead all aspects of process validation, as well as draft documentation for regulatory filings to advance Kite's product portfolio.

Responsibilities:
  • Lead, develop and implement scientifically sound and fit for purpose global validation policies and procedures based on current regulations, industry standards and industry practices for cell therapy.
  • Create and promote process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites. This includes providing leadership and direction for Site MSAT and manufacturing Technical SMEs to define the validation requirements for execution of aseptic or closed system process.
  • Develop and maintain qualification responsibilities include technical support for equipment qualification standards, framework for harmonized risk-based qualification strategies for similar equipment and unit operations across plants and alignment of PQ activity with process and operational requirements.
  • Based on product and process lifecycle requirements, define and establish sound scientific approaches for risk evaluation of global process change impact on process validation and comparability.
  • Interface internally with process design, analytical development, technical development, Global/Site MSAT and process technical leads and cross-functionally with Quality, Manufacturing and Engineering to implement new processes and technology as part of technology transfers.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
  • Work with vendors and suppliers to define requirements and understand functional specifications.
  • Support investigation, identify root cause for critical deviations during process validation and resolve CAPA for manufacturing.
  • Write, Review/Approve user documentation such as validation master plans, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing in alignment with Kite Global SOPs.
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment process issues.
  • Be capable of developing, growing and leading technical talent in cell therapy equipment qualification and process validation


Qualifications:
  • 10+ years of equipment and process validation, technology transfer or pharmaceutical manufacturing experience and a MS or MBA degree or; 12+ years of the aforementioned experience and bachelor's degree in science or related field.


Preferred Responsibilities:
  • 15+ years of equipment and process validation, technology transfer or pharmaceutical manufacturing experience
  • Cell culture, cell therapy or aseptic processing experience
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) with process validation experience
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability
  • Experience in statistical analysis using JMP or Minitab
  • Consistent record of leading and running multi-functional teams
  • Knowledge of data management tools and statistical process
  • Ability to think critically, and demonstrated problem-solving skills
  • Excellent interpersonal, verbal and written communication skills as well as digital literacy
  • Ability to function efficiently and independently in a changing environment
  • Proactive and willing to accept temporary responsibilities outside of initial job description


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

#ind123

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.