Associate Director, Manufacturing

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.

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. Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as an Associate Director, Manufacturing Technical Services in our new viral vector manufacturing facility in Oceanside, California.

In this role, you will report to the Senior Director of Manufacturing and represent Manufacturing on multi-disciplinary teams including those responsible for technology transfer and product lifecycle management, quality record management, process investigations and improvements, and site projects. This person is responsible for leading a team of process engineers while developing and executing the Manufacturing Support strategy for the specific Technical Operations programs associated with overall product strategy.

You will provide an in-depth understanding of the manufacturing processes and ensures all aspects of Manufacturing are carefully considered cross-functionally as part of the program commercialization strategy and execution. Using program management tools, you will be responsible for maintaining alignment with the Technical Operations Team on Manufacturing timelines and deliverables. As this position is a key collaborator with internal and external partners, strong interpersonal skills are critical.

Key Responsibilities:

• You'll represent Manufacturing Support for the manufacturing site and collaborate cross-functionally with other Team members.
• You'll be responsible for new product introduction with direct collaboration with sending organizations
• You will support technology transfer from process development to manufacturing
• You'll handle authoring and owning manufacturing batch records, including those within an electronic Manufacturing Excellence System
• You will own quality records for Manufacturing and work towards successful and timely resolution
• You will collaborate with other functions including Process Development for manufacturing investigations and process improvements
• You will lead and/or participate in site projects related to process, system, and process equipment improvements
• Build content and provide technical training to manufacturing and other site staff to support new product/process introductions and changes
• Actively participate in and facilitate decision-making.

Basic Qualifications:

• Bachelor’s Degree with 10 years of experience with a focus in science, operations, or engineering; or a Masters Degree with 8 years of experience noted above; or PHD with 2 years of experience note above; or a High School degree with 14 years of experience noted above

Preferred Qualifications:

• Advanced degree in Science or Engineering.
• 10+ years of experience in the biotechnology/ pharmaceutical industry including leadership roles (e. g., team leadership or functional leadership roles) in Manufacturing or key Operations functions (e. g., Process Development/Manufacturing Sciences, Quality, Supply Chain).
• Additional diverse assignments in Operations support (Program Management, Planning, Compliance, Engineering, etc.) and ex-Ops functions (Regulatory Affairs, Clinical Development, etc.).
• Knowledgeable of pharmaceutical product commercialization and life cycle management with a focus on product commercialization.
• Ability to recognize strategic implications of complex product development activities and effectively lead them cross-functionally.
• Ability to collect, digest and communicate information through relevant business analyses to influence decision-making.
• Ability to communicate vertically and horizontally through multiple channels, leverage contact network to motivate diverse teams, and enable cross-functional collaboration.
• Ability to manage and operate within a matrix environment.
• Proven functional or team leadership skills and proven management by influence.
• Excellent presentation skills to different audiences.
• You inspire trust and respect.

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.