Supervisor, Quality Control

Kite Pharma • Frederick, MD

1d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work. Join us in our mission! We are seeking a highly motivated individual to join us as a Supervisor, Quality Control Analytical, reporting to the Associate Director, Quality Control in Frederick, MD. In this role, you will be responsible for tasks associated with managing a group responsible for analytical testing and release of cell therapy final product using techniques such as qPCR/ddPCR, Flow cytometry, Cell-culture-ELISA and will have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Administration (MM) and teams. You will be responsible for the day to day oversight of the QC Analytical team during a 40-hour work week. Overnight shift, Monday through Friday, 11:00pm to 7:30am

Requirements

• 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

Nice To Haves

• 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.

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

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees