Kite Pharma
Supervisor, Quality Control - Analytical
Kite Pharma, Frederick, Maryland, United States, 21701
Job Opportunity: Supervisor, Quality Control Analytical
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. 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 Management (MM) and Corporate teams. You will be responsible for the day to day oversight of the QC Analytical team during a 40-hour work week, on the Swing shift, Wednesday through Saturday, 3:00pm to 1:30am. This shift is subject to change. Key Responsibilities (include but are not limited to): 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 direct 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 Other duties as assigned Basic Qualifications: 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 Preferred Qualifications: Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution 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. The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. 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 Management (MM) and Corporate teams. You will be responsible for the day to day oversight of the QC Analytical team during a 40-hour work week, on the Swing shift, Wednesday through Saturday, 3:00pm to 1:30am. This shift is subject to change. Key Responsibilities (include but are not limited to): 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 direct 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 Other duties as assigned Basic Qualifications: 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 Preferred Qualifications: Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution 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. The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.