Associate Director of Materials Technology and Process Engineering - Global MSAT

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 03, 2020
Ref
R0015162
Required Education
Masters Degree/MBA
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. Join us in this mission!

Kite is seeking a highly motivated individual with plastic design and manufacturing experience to join us as our Associate Director of Materials Technology within our Global Manufacturing Sciences and Technology (GMSAT) group based out of Santa Monica, CA, reporting into the Head of Materials Technology within the Global MSAT. In this role, the Associate Director will have a key global role within Kite's Process Development and Technical Operations functions to help develop technical and strategic direction for single-use consumable systems and materials used in the clinical and commercial cell therapy, and commercial viral vector manufacturing.

As a member of GMSAT Materials Technology group, the Associate Director (internally known as the Associate Director of Process Engineering) will contribute to success of Technical Operations goals by analyzing new GMP materials, determining if a material is fit for GMP implementation and continued material verification of existing critical raw materials (including single-use consumable systems, primary packaging materials, filters etc.) utilized for cell therapy manufacturing process and finished product. We would love the ideal candidate to have experience in the area of cell therapy manufacturing materials and an excellent understanding of global regulations and plastic manufacturing processes.

Responsibilities (included but not limited to):
  • Act as the technical subject-matter expertise (SME) throughout the internal and external network regarding manufacturing processes for plastics, such as injection molding, blow molding, extrusion molding, and lay flat manufacturing and polymer science
  • Participate in evaluation and development of new materials & technologies for process automation, and ensure material readiness for introduction into GMP manufacturing
  • Provide technical feedback in the development of requirements/specifications for new GMP materials (including single-use consumable systems, primary packaging materials, filters etc.) and secondary source material selection utilized for cell therapy manufacturing process and finished product, in collaboration with Process Development, site MSAT, manufacturing, supply chain, quality assurance operations, supplier quality and external vendors
  • Review and provide technical support as needed for regulatory filings and health authority questions
  • Facilitate and support multi-functional investigation, identification of root-causes and CAPAs at internal manufacturing sites, and external vendors in collaboration with site MSAT and supplier quality
  • Help develop an end-to-end material lifecycle strategy for material being received from development into clinical and commercial manufacturing.
  • Develop strategy and continued material verification plan of existing critical raw materials
  • Provide technical leadership and mentoring to the team for effective teamwork and material transfer into manufacturing
  • Collaborate with key suppliers/partners & customers including Manufacturing, Quality, Supply Chain, Regulatory, and others within Technical Operations
  • Act as delegate to the Head of Materials Technology, participate in multi-functional materials team (e.g., Global Raw Material, GMLT sub team)


Requirements:
  • Master's Degree in Engineering, Science, Biotechnology or related field with 8+ years of experience in plastic manufacturing, design or process development, or design transfer OR Bachelor's Degree in Engineering, Science, Biotechnology or related subject area with 10+ years of experience in plastic manufacturing, design or process development, or design transfer


Preferred Qualifications:
  • Solid understanding of cell culture, plastic manufacturing and assembly, container and closure systems, cell therapy delivery devices & packaging and automation technologies
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals or medical devices
  • Good understanding of material qualification, tech transfer and process validation
  • Knowledge of QbD, Lean Manufacturing, and/or Six Sigma
  • Successful track record as materials SME collaborating with both internally and external materials suppliers
  • Self-motivated, excellent prioritization, problem-solving and investigation skills
  • Great teammate with excellent 360-degree interpersonal skills


Does this sound like you? If so, feel free to apply!

#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.