Supervisor, Manufacturing - Viral Vector

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.