Manager, Validation

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Nov 05, 2020
Ref
R0015996
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

We are seeking a highly motivated individual for the role of Manager Validation to work in this exciting new area of cancer immunotherapy! This role has the primary responsibility for the oversight of the facilities, utilities and equipment qualification and validation program at our Commercial Manufacturing Location in El Segundo, CA. This role reports directly to the Head of Engineering and Commissioning, Qualification and Validation at the site.

Responsibilities (include but not limited to):

  • Provides leadership and guidance to site validation team, with clear goals and expectations
  • Leads the day-to-day activities of the Facilities, Utilities and Equipment Qualification, Requalification and Periodic Review programs.
  • Develops internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan based on the best available scientific evidence and professional judgment in collaboration with the Facilities and Engineering network
  • Works on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations.
  • Responsible for performing the validation of equipment, utility systems, facilities and/or automation systems for projects. This includes developing project plans, preparing protocols, analyzing test results, and preparing technical reports.
  • Contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing.
  • Coordinates the activities of validation and contract personnel, ensuring the quality of completed work. Provides technical assessment and validation approval for engineering and process changes.
  • Reviews protocols, reports and data tables generated by peers and contract personnel.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
  • Provides department leadership and presents validation packages for internal and external compliance audits and acts as primary interface with regulatory agencies for the validation team.
  • Ensures projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and Kite/Gilead Standards.
  • Responsible for staff development, managing high performing teams, budgeting and cost control, talent mapping, succession planning, the development of strong leaders within the function.
  • Manages validation personnel, including organizing and prioritizing department goals & objectives, performing training, writing performance reviews, resolving people management issues for direct reports.
  • Coordinates contract personnel through completion of assignments.
  • Independently manages assigned projects through completion, includes managing and audit field support as required.
  • Supports senior leadership in creating and implementing mid-long term plans for department.
  • Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
  • Demonstrates ability in managing competing priorities, creating an effective team environment.

 


Basic Qualifications:

 

 

  • Master's degree with 5+ years of experience in validation, engineering Or
  • BS degree with 7+ years of experience in validation, engineering

 


Preferred Qualifications:

 

 

 

 

  • In-depth understanding and application of validation principles, concepts, practices, and standards.
  • In-depth knowledge of current Good Manufacturing Practices (cGMPs).
  • Extensive working knowledge of facilities, utilities, equipment and systems and industry practices.
  • Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
  • Strong program and change management skills
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.
  • Able to adjust workload based upon changing priorities
  • Up to 10% travel
  • Previous people management experience highly desired.
  • Advanced degree in engineering or related area of study highly desired.
  • Demonstrates in-depth knowledge of state of the art principles and theories and industry practice.
  • Knowledgeable with cGxP as well as regulatory regulations and compliance requirements for cell therapy manufacturing
  • Able to express ideas and present information effectively to Kite leadership, within team functions, and with external partners
  • Ability to think critically with demonstrated troubleshooting and analytical skills

 


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.