Hiring company: Kite Pharma
We are seeking a highly motivated individual to join us as a Team Lead, Quality Control Lab Support, reporting to the Manager, Quality Control Lab Support in Frederick, MD. In this role, you will execute tasks associated with Sample Management, Raw Material Release, Shipping, System Administration and other Lab Support QC functions, and will 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 MM, 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 routine 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 and 3+ years’ experience working in Quality Control or biopharma laboratories OR
- Bachelor’s Degree and 5+ years’ experience working in Quality Control or biopharma laboratories OR
- High School Degree and 9+ years’ experience working in Quality Control or biopharma laboratories
Preferred Qualifications:
- 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 build 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-paces small company environment with minimal direction and able to adjust workload based on changing priorities.
Dos this sound like you? If so, apply today!
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.