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Supervisor, Manufacturing - Viral Vector

米国 - カリフォルニア - オセアニア製造・サプライチェーン正社員

仕事内容

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. Join us in our mission!

We are seeking a highly effective Supervisor, Manufacturing to be responsible for supervising a team of Manufacturing Associates at our Oceanside, CA site.

Responsibilities (include but are not limited to):

  • Supervise employees and manufacturing activities to meet the site goals and priorities. Provides daily job assignments with manufacturing staff and other cross functional departments. Hire new employees.
  • Execute end to end unit operations for the manufacture of viral vector products in a cGMP environment using proper aseptic technique, good documentation practices, and sound scientific methods.
  • Plans the proper and timely development and training of employees. Responsible for performance management of employees (Manufacturing Associates).
  • Develop technical expertise in area of responsibility and provide technical instruction/training on current and new/improved processes to appropriate audiences, primarily Manufacturing Associates
  • Interface cross functionally to resolve production, supply, and equipment issues.
  • Review of documentation including but not limited to batch records, logbooks/forms, and procedural revisions.
  • Manage or own quality system records including deviations, CAPA’s, change controls, DCC’s, etc.
  • Implement and reinforce practices that drive safety for all operational activities.
  • Provide support to integrate best practices, where appropriate, into manufacturing. Support process improvement initiatives.
  • Perform routine One-on-One’s and check-ins with reports, along with mid and annual year review delivery.
  • Additional duties as assigned; these duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

  • Master’s degree with 3+ years of experience in manufacturing in a biotech/pharma industry Or
  • Bachelor’s degree with 5+ years of experience in manufacturing in a biotech/pharma industry Or
  • High School degree with 9 + years of experience in manufacturing in a biotech/pharma industry

Preferred Qualifications:

  • 6+ years of experience with bachelor’s degree in biology or related scientific discipline, or equivalent combination of experience and education.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Prior experience with biopharmaceutical, cell or gene therapy manufacturing across Upstream, Downstream and filling operations is a plus.
  • Knowledge and experience with single use systems including chromatography, UFDF, and bioreactors.
  • Experience with automation platforms and electronic batch records.
  • Knowledge of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) a plus
  • Excellent skills in Microsoft Word, Excel and data analysis
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.
  • Excellent interpersonal, verbal and written communication skills
  • Willingness to think outside of the box as well as comfortable in an exciting and constantly evolving diverse and inclusive environment.
  • Ability to lift 40 lbs. repeatedly and stand for hours at time.
  • Able to work off shift hours and weekends, as well as provide the on-call support as required.