For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
As Senior Engineer for Manufacturing Science and Technology (MSAT) youll be joining a newly formed team, in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. Youll be reporting to the Director MSAT EU.
About Kite Pharma, A GILEAD Company
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 Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. Were building a state-of-the art manufacturing site in the Netherlands (Amsterdam-Hoofddorp).
Were currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
As a Senior Engineer (MSAT) you will provide process engineering support for technology transfers, process and product comparability, process validations and GMP manufacturing for Kites engineered autologous T cell therapy products.
Additionally, you will write product impact assessments, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
You will work with the Process Development, Manufacturing and Quality teams to implement and scale-out cell therapy processes, support process validation, as well as draft documentation for regulatory filings to advance Kites product portfolio.
Your key responsibilities will be:
Work closely with Process Development teams to assure process reliability and robustness in preparation for comparability and process validation.
Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
Work with vendors and suppliers to define requirements and understand functional specifications
Support investigation, identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPA for manufacturing
Write and review technical documentation (batch records, SOPs, protocols & reports for equipment qualifications, comparability, process and cell therapy manufacturing process validation testing)
Participate and report to a cross-functional development team to advance production activities
Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
Other duties as assigned
Your qualifications are:
Degree in Biochemical Engineering, Biotechnology or Life Sciences with at least 7 years of pharmaceutical manufacturing, technology transfer & process development experience required
Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
Mastery of scientific and engineering principles
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
Ability to think critically, and demonstrated troubleshooting and problem solving skills
Excellent interpersonal, verbal and written communication skills
Ability to function efficiently and independently in a changing environment
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Well-developed computer skills
Process validation experience
Understands and employs principles and concepts of Lean Six Sigma to improve process capability
Experience in statistical analysis using JMP or Minitab
Excellent people management skills, able to build and lead a team as well as train entry-level personnel
Knowledge of data management tools and statistical process controls
This position may require travel up to 10% of time.
As soon as the site is operational (2020) this role requires off-shifts, irregular hours and weekend shift
Flexibility/availability for a training in the USA
Would you like to know more before you apply? Please contact Jose van de Beek – Talent Acquisition Business Partner, via: CareersEU@kitepharma.com .
Only candidates in possession of a valid EU work permit will be considered.
Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.
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 .
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.