Senior Supervisor, Analytical Development

Job Code:

P1035

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Post Date:

October 14, 2021

JOB DESCRIPTION

The role of the Supervisor/Senior Supervisor, Analytical Development is to serve in a leadership role to oversee the design, execution, and data analysis of analytical test methods, in accordance with all applicable regulations and guidelines.

 

The key responsibilities of this role will be to coordinate the development, transfer, optimization, and qualification/validation of analytical test methods.  Performance of analytical methods may be required.  The ideal candidate will have advanced, practical, as well as theoretical, knowledge and experience with multiple analytical methods in a cGMP environment.  These assays include, but are not limited to, cell-based assays (potency, activity), viral titration methods (plaque assay, TCID50), DLS, ddPCR, qPCR, HPLC, ELISA, FACS, as well as mammalian tissue culture.

This position will oversee and coordinate the execution of assigned analytical development activities, related testing, data organization, interpretation, and reporting of results by analytical scientists.  This individual will also ensure laboratory instruments and equipment are used properly, as well as maintenance and calibrations are up to date.  The Supervisor/Senior Supervisor will author, edit, and review standard operating procedures (SOPs), Test Methods, Qualification and Validation protocols, and reports. 

The successful candidate must be capable of thriving in a matrix environment, regularly interfacing with personnel in QC, QA, PD, and other departments.  The Supervisor/Senior Supervisor will also serve as technical lead for one or more projects, which will require interaction with clients, and/or other external collaborators or sponsors, while also meeting project goals and timelines.

RESPONSIBILITIES

  • Author, edit, and review a wide variety of documentation.

  • Coordinate the training, activities, and profession growth of Analytical Development Personnel.

  • Ability to make decisions and recommendations.

  • Attend required meetings.

  • Assist in resolving instrumentation issues, as well as OOS, and OOT scenarios.

  • Capable of coordinating multiple experiments at one time, under minimal supervision, without compromising quality.

  • Maintain professionalism with management, personnel, collaborators, and clientele.

  • Collaborative team player who will assist others and ask for assistance as necessary.

  • Adept at gathering, organizing, analyzing, and reporting data and information

  • Expert foundation in the design and execution of analytical methods and associated results reporting. 

  • Ensure personnel are properly trained in the use of laboratory equipment and instrumentation.

  • Must be able to communicate effectively through oral and written means.

  • Well organized with effective time management and attention to detail.

  • Advanced knowledge of cGMP, ICH guidelines, and biological safety is required.

  • All other duties as assigned.

QUALIFICATIONS

  • Demonstrable leadership/supervisory experience in a relevant area required

  • Ph.D. in a related field, with 3 years relevant experience.

  • M.S. in a related field, with 6 years relevant experience.

  • Virologist strongly preferred