Kite Pharma · 1 day ago
Supervisor, Quality Control
Frederick, MD
Full-time
Onsite
Mid, Senior Level
$107K/yr - $139K/yr
3+ years expKite Pharma is a biopharmaceutical company dedicated to curing cancer through innovative therapies. They are seeking a Supervisor for their Quality Control Analytical team, responsible for managing analytical testing and ensuring compliance with regulatory standards while fostering team development.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Training on Analytical Assays using qPCR/ddPCR, Flow cytometry, Cell-culture-ELISA
Supervise all QC Analytical laboratory testing using qPCR/ddPCR, Flow cytometry, Cell-culture-ELISA
Responsible for the efficient operation of the QC Analytical labs including the planning, coordination and supervision of activities conducted by QC Analysts
Manages QC Analytical training program
Hire, mentor and develop exceptional QC personnel
Works with QC raw materials team to establish testing process of raw materials
Generates of CoAs for product release
Develops, revises, and reviews SOPs, tech transfer/qualification/validation protocols and reports
Conduct and/or develop investigation of OOS, aberrant results and trends in invalid assay in product and raw material testing
Develop and author deviations related to QC Analytical procedures to investigate root cause, impact and corrective and preventative actions
Participate and/or lead daily and weekly team meetings
Monitors the GMP systems currently in place to ensure compliance with established SOPs, Policies, cGMPs and other relevant regulatory requirements. Conduct investigations to support deviations when preferred
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
Author controlled documents such as SOPs, forms, etc., as needed
Participate and Support development and implementation of Operational Excellence initiatives to enhance laboratory and staff efficiencies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
Other duties as assigned
Qualification
Required
MA / MS Degree with 3+ years of analytical and/or cGMP operations and/or quality experience OR
BA/BS Degree with 5+ years of analytical and/or cGMP operations and/or quality experience OR
High School Degree with 9+ years of analytical and/or cGMP operations and/or quality experience
Preferred
Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry
Demonstrated guidance and overseeing skills, including establishing direction and goals, and guiding implementation while fostering a team-based environment
Well versed in various analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays and other applicable methods for the testing of biopharmaceuticals
Excellent 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, GLP
Ability to effectively negotiate and deliver collaboration within teams and amongst team members
Demonstrated ability to create and maintain highly functioning teams
Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Mark Jurgens
Vice President, Global Head of Evidence Generation & Strategic Collaborations
Craig Vermeyen
Director, Packaging and Labeling
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-07
Company data provided by crunchbase