Senior Manager, Clinical Viral Vector Manufacturing, Operations

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Aug 20, 2020
Ref
R0014841
Required Education
Bachelors Degree
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

This Individual will be an integral member of the viral vector team at Kite. They will manage and oversee logistics and operations related to day to day activities of the large scale production of the various viral vectors/platform in the RDMC clinical vector facility. The individual will be accountable for successful operation of the clinical viral vector facility, hence supporting a team of specialists in the viral vector manufacturing area. They will help start-up of GMP operation of the vector facility, while contributing to build-up all of the supporting infrastructure required for GMP operation. For example, areas in which this individual can potentially lead or contribute to their build-up and maintenance in support of the clinical vector facility are: management and procurement of raw materials, equipment installation and maintenance, process monitoring and documentation, drafting of Standard Operating Procedures (SOPs) and batch records, final product storage, and providing process samples for release testing. The individual will be ultimately responsible for compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices in the clinical facility.

Responsibilities (include but are not limited to):

  • Lead and provide oversight on activities to ensure facility operational readiness for production of clinical grade viral vector material
  • Build systems to support day to day operation and planning of the clinical manufacturing operation by:
  • Managing installation and commissioning of the required equipment
  • Establish operational objectives/goals and efficient support systems for appropriate task assignments
  • Establish logbooks or equivalent system to monitor equipment usage and their application
  • Work closely with QC, QA and supply chain representatives to ensure proper steps are in place for procurement of raw material, testing and release of the final vector product
  • Work closely with QC and QA to ensure proper cleaning protocols are established and maintained
  • Work with QC and QA to build a system to transfer samples, test and report data for process monitoring and final product release
  • Oversee the development of necessary documentation related to clinical manufacturing operations (i.e. batch records, SOPs, sampling plan and process monitoring data and reports)
  • Communicate, interact and work closely with viral vector development leadership team and other cross functional department heads with the following aims:
    • Successful operation, scale up and robustness of the transferred viral vector processes for upstream, downstream, formulation and fill finish
    • Own and manage plant schedule and all subordinate activities to ensure fulfillment of the GMP/Clinical and non- GMP demands of viral vector
    • Ensure vector request needs for development and research purposes (non-GMP material production) are fulfilled in a timely manner with planning and scheduling
    • Maintain vector material inventory and coordinate material fulfillment with Lab Ops team to facilitate vector dispense requests
  • Create an environment where productivity and efficiency are achieved and recognized
  • Manage inspection activities, observation commitments to address any potential inspection issues that impact plant operations
  • Drive business standards and a high level of compliance through effective monitoring and reporting of key performance metrics
  • Contribute to filing document and submissions and agency requests related to the manufacturing plant
  • Maintain a high level of compliance through effective monitoring and reporting of key quality metrics
  • Ensure timely execution of CAPA, change control and continuous improvement initiatives
  • Identify key areas for change and alignment and mobilize organization to make changes happen
  • Contribute to operational team build up and conduct necessary training to the operational personnel to ensure compliance with regulatory guidelines and requirements for safety of the product and personnel.
  • Develop and administer budgets, schedules, objectives and goals


Requirements:
  • Bachelors degree in biology or related field with 8+ years of experience, or Masters degree preferred with 6+ years of experience managing a manufacturing team in the biotechnology or biologics industry, preferably with 5+ years as a leader of leaders
  • Strong understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilities
  • Knowledgeable of the current Regulations, Code of the Federal Regulations (CFRs) and Current Good Manufacturing Practices (cGMPs)
  • Expert knowledge of electronic quality systems
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willingness to think outside of the box and adapt best practices to our small, but growing environment
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • Previous viral vector or biologics traditional process experience is desired


#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.