Gilead Sciences, Inc. Director, Process Design in Santa Monica, California
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 at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job
Kite is seeking a highly motivated leader with process development experience to work on innovative T cell therapy for cancer treatment. The 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 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 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 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
Ph.D in Biochemistry, Molecular Biology, Biochemical Engineering, or equivalent, with 8+ years of process development experience
Masters degree with 10+ years of process development experience
Bachelors degree with 12+ years of process development experience
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 is a plus
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 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 at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.
Change The World With Us
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.