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Job Description

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 execute 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.

As the site transitions into operations mode, you will be responsible for the day to day oversight of one of the QC Analytical teams. This group will operate 7 days a week, with an extended, overlapping shift structure. This role will start as a 5day/8hr shift position and will move to a 4 day /10 hour shift position

Position 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 manage investigation of OOS, aberrant results and trends in invalid assay in product and raw material testing.
• Manage 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 required.
• 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 maximize laboratory and staff efficiencies
• 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 QC Analytical OR
• Bachelor?s Degree and 5+ years? experience working in QC Analytical or biopharma laboratories
• High School Degree and 9+ years? experience working in QC Analytical or biopharma laboratories

Preferred Qualifications:

• Experience supervising/managing analytical 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, GLP
• Ability to effectively negotiate and build collaboration within teams and amongst individuals.
• 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.
  

Does this sound like you? If so, apply today!

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