Associate Director, Head of CMC Technical Writing

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 18, 2020
Ref
R0015374
Required Education
Bachelors Degree
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 CMC experience for leading a Technical Writing function as well as authoring and reviewing regulatory submission sections and documents for clinical and marketing applications. As a leader of this function, the incumbent will also be responsible for strategic planning and management of the CMC Technical writing function in alignment with business goals. The position will be collaborating with the Process Development teams as well as the Regulatory Affairs, Manufacturing and Quality teams to ensure the submission content fulfills the scientific and regulatory needs, as well as aligned across various functions. The position will be located in Santa Monica, CA.

Key Responsibilities

  • Lead a function of CMC Technical Writers, which entails the following:
  • Manage other CMC Technical Writing staff by providing mentorship for authoring various regulatory filings including IND, IMPD, BLA, MAA etc
  • Establish strategies for authoring regulatory documents in collaboration with functional subject matter experts and CMC-Regulatory function
  • Plan and deploy resources to the various technical writing projects
  • Lead other Technical Writers by coaching and mentoring for their ongoing performance improvement and career development
  • Proactively determine resource needs and capability gaps for the function, and work with management to strengthen the Technical Writing function in alignment with the needs of Kite's growing pipeline
  • Independently serve as the primary author of CMC documents intended for Marketing Application submissions to Global Health Authorities. Assume ownership for the CMC sections of the regulatory writing by ensuring key messages are clear and consistent within and across documents
  • Interpret and summarize complex portions of data from multiple departments into regulatory documents aligned with the established strategy.

 


Requirements:

 

 

  • Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 10+ years (Bachelors), 8+ years (Masters), or 6+ years (PhD) of proven experience in biopharmaceutical and/or cell and gene therapy
  • Experience participating in and leading regulatory submissions for US, EU and other major regions, as well as associated project and functional teams
  • Demonstrated knowledge of manufacturing of biotechnology and/or cell therapy products, aseptic processing and process development
  • Detailed knowledge of biologics process development is crucial. Cell therapy process development experience is helpful
  • Knowledge of key aspects of product lifecycle, including product and process development, as well as requirements for validation, clinical & commercial manufacturing, and regulatory submissions
  • Working knowledge of regulatory requirements for biologics, pharmaceuticals, and medical devices. Cell therapy experience is highly desirable.
  • Demonstrated ability to lead a group of technical writers and/or scientific staff
  • Excellent collaborator that can work effectively with subject matter experts in various CMC functions at multiple sites and geographies, with minimal direction
  • Excellent troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills

 


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 to apply for this job.