Team Lead, Quality Control Lab Support

Job Description

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. Would you like to join us in this mission?

We are seeking a highly motivated Team Lead, Quality Control Lab Support, to support the startup of Kite’s brand new, state of the art, commercial Cell Therapy facility currently under construction in Frederick, Maryland.

In this role, you will report to the Manager, Quality Control Lab Support and will execute tasks associated with the Sample Management, Shipping, and other Lab Support QC functions, as well as have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.

As the site transitions into operations mode, you will be responsible for the day to day oversight of one of the QC Lab Support teams. This group will operate 7 days a week with an extended, overlapping shift structure.

Additional Responsibilities (include but are not limited to):

• Assist the Manager, Quality Control Lab in implementing processes to support Lab Support functions during start activities.

• Serve as lead for one of the teams within QC Lab Support.

• Execute processes to support sample receipt and processing for release / stability samples for testing and retains.

• Work with Materials Management, QA and other QC functions including Corporate QC to implement and support requirements around Raw Material sampling, testing and disposition.

• Manage and complete all shipping activities within all QC functions.

• Perform System Administration functions for QC Equipment.

• Complete route record review of records, e.g., of sample chain of custody, processing, logbooks and other documentation generated within QC Lab Support.

• Author controlled documents such as SOPs, forms, etc., as needed.

• Conduct investigations to support deviations when required.

• Provide updates at daily and weekly meetings.

• Monitor the GMP systems currently in place to ensure compliance with documented policies

• Participate in Lean Lab and other Operational Excellence initiatives in the group.

• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

• Other duties as assigned

Basic Qualifications:

Master’s Degree with 3 years of relevant experience

OR

Bachelor’s Degree with 5 years of relevant experience

OR

High School Degree with 9 years of relevant experience

Preferred Qualifications:

• Bachelor's degree or advanced degree in Biotechnology, Biological Sciences or related discipline

• Experience working in Quality Control in biopharma laboratories

• Experience supervising/managing analytical biology labs within the biotechnology or pharmaceutical industry

• Well versed and experienced in bioanalytical methods working under GMP conditions.

• Strong experience in applying GMP in QC lab in conformance to US, EU and ROW standards.

• Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.

• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs,

• Ability to effectively negotiate and built collaboration within teams and amongst individuals.

• Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment

• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.

Does this sound like you? If so, please apply today!