Senior Lead Process Engineer - Polymer Biomaterials and Plastic Containers

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 01, 2020
Ref
R0015604
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?

Kite is seeking a highly motivated individual with process development, materials science, and polymer manufacturing experience to work on the Process Technology and Materials Development Team within Process Development as a Senior Process Engineer (SPE) in our Santa Monica facility. As a Senior Process Engineer II as the position is known internally, you will evaluate new materials (reagents, single use materials, and device kits) for application to next generation cell therapy processes. Further, the SPE will support material changes, material investigations, and material second-sourcing efforts for our current commercial cell therapy processes. The SPE will also conduct risk analysis and project management to demonstrate feasibility of new materials and ensure that project objectives are achieved on time.

Responsibilities of the Senior Lead Process Engineer - Polymer Biomaterials and Plastic Containers include:
  • Prioritize new materials based on business objectives and evaluate feasibility
  • Support material changes, material investigations, and material second-sourcing efforts
  • Complete material assessments, oversee lab studies to evaluate feasibility and mitigate risks, analyze results, communicate findings in reports and presentations, and maintain materials knowledge database
  • Manage material extractables / leachables program
  • Interface cross-functionally with Process Design, MSAT, Manufacturing, Supplier Quality, Supply Chain, Quality, Regulatory, and external partners
  • Understand, communicate, and apply regulatory requirements in selection, testing, and qualification of final container and in-process GMP manufacturing materials
  • Leverage experience with polymer manufacturing to support investigations with single-use material failures in the cell therapy manufacturing process
  • Apply polymer manufacturing expertise to assist Supplier Quality and Kite's suppliers with corrective and preventative actions at vendor sites for Kite's single-use materials


Requirements:

PhD

OR

MS/MA Degree with 6+ years of manufacturing, process automation & process development experience

OR

BS/BA Degree with 8+ years of the above-mentioned experience

OR

High School Degree with 12+ years of the above-mentioned experience

Preferred Qualifications:
  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices
  • Thorough knowledge of pharmaceutical Process Development is essential.
  • Cell culture and aseptic processing experience
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
  • Knowledge of product lifecycle - Product and process development, clinical trials, validation and regulatory submissions, and commercial GMP manufacturing
  • Experience with evaluation of new technologies as applied to bioprocessing and cell therapy
  • Experience in materials science and evaluation of biocompatible materials (i.e. extractables / leachables)
  • Experience with risk management methodology
  • Excellent interpersonal, verbal, and written communication skills
  • Demonstrated experience working on a team with emphasis on communication skills and contributions to team-based decisions
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to think critically and have demonstrated troubleshooting and problem-solving skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description


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.