Associate Director of Analytical Operations and Development

Employer
Kite Pharma
Location
Gaithersburg, MD, United States
Posted
Sep 16, 2020
Ref
R0015332
Required Education
Doctorate/PHD/MD
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

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 of Analytical Operations to lead a diverse team developing advanced analytics to provide testing support in Kite's state of the art research and clinical production facility located in Gaithersburg, Maryland. This facility focuses on the new, meaningful field of fully personalized T-cell neoantigen reactive therapy for solid tumors using individual patient neoantigen TCRs.

The Associate Director will assume a leadership role in the development of analytical strategies as well as focus on the assessment of novel analytical technologies, perform platform assessment, and deep characterization of cell therapy products. The Incumbent will also define the analytical control strategy aligned with product CQAs in addition to lead transfer and lifecycle management of analytical methods, etc. to enable process development, product characterization and release testing. Additionally, the Associate Director will build, manage, and mentor a technical team to deliver data, documentation, and knowledge transfer.

Responsibilities of the Associate Director of Analytical Operations include:
  • Provide strategic, technical and scientific leadership to the analytical development team
  • Accountable to advance and implement analytical capabilities, build and manage a highly technical team
  • Lead analytical activities for extended characterization of cell therapy products enabling process improvements and efficiencies
  • Oversee assay development activities from conception through, optimization, qualification, and method transfer to Quality Control
  • Collaborate with a cross-functional team to advance development of T cell therapy products
  • Serve as SME and technical advisor on method validation, method transfer, comparability/bridging protocols
  • Author, review and approve technical reports, documents (e.g., analytical methods and protocols, SOPs, etc.) as well as regulatory documents
  • Accountable for developing and executing cell therapy CMC strategies to enable and deliver IND and commercial filings
  • Collaborate closely with key line functions and communicate sophisticated data/decisions within department and cross functionally
  • Responsible for integrating scientific/technical efforts around cross-functional issues


Requirements:

Ph.D. degree in a relevant scientific field including (Immunology, , Molecular, Cell or Cancer Biology) with 2+ years' experience of pharmaceutical manufacturing of biotechnology products, analytical method development, technology transfer, method qualification / validation and process development OR MSc Degree (similar fields mentioned previously) and 8+ years of the aforementioned experience OR BS Degree (similar fields mentioned previously) with 10+ of the aforementioned experience

Preferred Qualifications:
  • Significant experience in advanced analytical platforms and method development/qualification and/or validation of cell and gene therapy methods including cell-based assays, cytotoxicity assays, flow cytometry and/or single cell-based molecular assays
  • Successful track record in leadership, people management and managing cross-functional interfaces and integrated teams.
  • Prior experience with regulatory filings i.e. IND, NDA or BLA a plus
  • Comfortable in a fast-paced environment, working with autonomy with an ability to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills


Does this sound like you? If so, please apply today!

#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.