Associate Director, Process Team Lead

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Jul 19, 2019
Ref
R0009093
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite is seeking a highly motivated individual with cell therapy or biopharmaceutical experience to coordinate development activities for Kite's CAR T cell programs and represent Process Development (PD) on the internal life-cycle Operations Team. Responsibilities will include oversight of product-related PD activities, leading project sub-teams in Process Development, driving projects for lifecycle activities, transformational projects, and being the point of contact for the Operations Team in Process Development (PD). The incumbent will be responsible for assembling and reviewing regulatory documents in support of INDs, RTQs, IND amendments and product licensure worldwide. The Process Team Lead will work closely with Process Development scientists, project leads and the Operations Team Lead to identify key deliverables and critical path components, and to assure that programs meet established timelines and deliverables.

Responsibilities include, but are not limited to:
  • Develop and ensure delivery of Process Development portion of CMC strategy in alignment with program, operations team, and organizational CMC strategy.
  • Engage with Process Development teams to ensure agreed deliverables and timelines align with corporate and program timelines
  • Lead Process sub-teams to ensure execution of operational deliverables and communicate with the Operations Team.
  • Enable quick and robust decision-making through effective communication
  • Lead Process Team through critical data analysis, activity planning and experimental review cross-functionally
  • Ensure required process information is available to support regulatory filings and review technical portions of Kite regulatory documents
  • Review technical documentation (project plans, reports, protocols, etc.) and ensure alignment with agreed CMC and regulatory strategy
  • Enhance project team collaboration through clear communication.
  • Identify Process Development risks and develop mitigation plans
  • Support outsourced development activities
  • Other duties as assigned


Requirements:
  • Ph.D degree in Science, Engineering or a related field with 3+ years' relevant industry experience in biopharma manufacturing/business; or Master's Degree in Science, Engineering or a related field with 5+ years' relevant industry experience
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology products, and understanding of cell product manufacturing and product development is a plus
  • Ability to think critically and demonstrate troubleshooting and problem solving skills
  • Proven knowledge of pharmaceutical manufacturing of cell/gene therapy & biotechnology products, aseptic processing, process and analytical method development, method qualification/validation and technology transfer,
  • Experience with viral vector systems and methods preferred
  • Experience in authoring SOPs and CMC sections of regulatory filings
  • Strong communication skills, meeting management, and verbal, written, and presentation skills.
  • Excellent skills in Microsoft Project, Word and Excel, with data analysis 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!

#LI-MH1

#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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