Associate Director, Process Engineering

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 individual with cell culture experience to work on innovative T cell therapy for cancer treatment. Reporting to the Head of Site Manufacturing Sciences and Technology, Associate Director, Process Engineering is a key leadership role within Kite Pharma's Process Development and Technical Operations. As an Associate Director you will provide technical and organizational leadership support to the commercial manufacturing for cell therapy. As a member of Site MSAT Leadership Team you are expected to oversee MSAT team's responsibilities for product/process response and investigations, project support, and process improvements. The ideal candidate must have experience in cell therapy and/or biologics, GMP manufacturing and excellent understanding of regulations.

Key responsibilities:

• Provide leadership to execution of process validation and comparability campaigns
• Prepare and conduct initial training for process improvements and new process introduction.
• Review and provide technical expertise to regulatory filings and health authority questions
• Effectively & efficiently communicate manufacturing process performance internally and externally.
• Ensure product supply is executed effectively against the S&OP and meets quality requirement
• Support the implementation of technology, automation and process transfer, gap assessment, master batch record, operation readiness, and execution of engineering, process validation and comparability campaigns, and communicate manufacturing process performance internally and externally.
• Develop and lead all aspects of the MSAT team's contribution towards investigations, impact assessment, new process training.
• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
• Lead projects to increase safety/compliance or improve process or equipment robustness
• Review and approve technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process and cell therapy manufacturing process validation testing)
• Lead/participate in Operational Excellence activities within Tier Structure.
• Participate and report to a cross-functional development team to advance production activities
• Other duties as assigned

Qualifications:

• PhD/MS/BS degree in Biochemical Engineering, Biotechnology or Life Sciences with at least 10+ years of biotech experience. Cell therapy experience is a plus.
• Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
• In-depth understanding of scientific and engineering principles
• Proven track record of leading and managing cross functional teams
• Previous experience with managing small teams is a plus

• Experience in statistical analysis using JMP or Minitab
• Knowledge of data management tools and statistical process controls
• Process validation experience is a plus
• Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
• Understand manufacturing needs and adapt to the changing needs of the manufacturing environment
• 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

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 jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.