Associate Director, Process Design

Kite Pharma
Santa Monica, CA, United States
Nov 11, 2020
Required Education
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 leader with process development experience to work on innovative T cell therapy for cancer treatment.The Associate Director will be a member of autologous process design (autologous PD) leadership as a life cycle management (LCM) group leader and represent autologous PD team in cross-functional meetings under the guidance of the lead of autologous PD team and the head of process design. The Associate Director will be accountable for delivering functional milestones to support CMC activities for commercialization and post-launch commitment for autologous products at Kite by providing technical expertise in technology transfer, GMP manufacturing support and also by providing approval for documentation pertaining to process characterization, qualification, and validation to meet regulatory requirements.The Associate Director will work with other autologous PD group leaders (early programs) to facilitate technology transfer to LCM group and also influence early programs at Kite by providing important lesson and learnt. The Associate Director will manage and oversee life cycle management activities of commercial products at Kite such as risk assessment, continuous improvement of processes, and process changes needed at global manufacturing sites.

Responsibilities include, but are not limited to:
  • Manage autologous PD LCM group to deliver functional milestones to support CMC activities
  • Provide technical guidance and mentorship to autologous PD LCM group for high quality data analysis and interpretation using advanced analytical tools (JMP, DX) for process characterization
  • Represent Autologous PD LCM in cross-functional discussion to advance product activities
  • Oversee and provide expertise on post-BLA/post-launch commitment to various regulatory agencies, ranging from providing guidance on execution of studies to reviewing and providing feedback on responses to regulatory agencies as process SME
  • Influence strategic decision and provide feedback as process SME on expansion of commercial products in US as well as ROW
  • Provide guidance to ensure successful clinical manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
  • Lead life cycle management tasks such as continuous improvement of processes and efficiencies, process changes at manufacturing sites, and cost reduction
  • Function as a point of contact of autologous PD for MSAT in global manufacturing sites
  • Influence early program teams by providing critical feedback that learnt from commercial products

Basic Qualifications
  • Ph.D in Biochemistry, Molecular Biology, Biochemical Engineering, or equivalent, with 2+ years of process development experience
  • Masters degree with 8+ years of process development experience
  • Bachelors degree with 10+ years of process development experience
  • High School Diploma with 14+ years of process development experience

Preferred Qualifications
  • Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Mastery of scientific and engineering principles
  • Practical experience in GMP operations
  • Experiences in process development in late stages (pivotal, BLA, and commercial products)
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, molecular biology, immunology, virology, gene-editing and cell therapy process development
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication skills; authoring regulatory responses
  • Experiences in managing a group or team with demonstrated leadership
  • Experiences in QbD approaches to mitigate risks associated with safety, process changes, process robustness and cost reduction
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience

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!

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 Sign up to follow @KitePharma on Twitter at

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For Current Kite Pharma Employees and Contractors:

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