Supervisor, Quality Control - Analytical
米国 - メリーランド - フレデリック品質保証正社員仕事内容
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
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
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.
Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities.
People Leader Accountabilities:
•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.