Scientist III, Analytical Development

Job Code:

P1011

/

Post Date:

January 11th, 2021

JOB DESCRIPTION

The role of the Scientist III, Analytical Development is to serve in an advanced technical role in the Analytical and Process Development laboratories.  The key responsibilities of this role will be to develop, transfer, optimize and qualify/validate test methods for client projects.  The Scientist III will be required to have advanced, practical 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), ddPCR, qPCR, HPLC, ELISA, FACS, as well as mammalian tissue culture.

This position will perform assigned analytical procedures, related testing, data organization, interpretation and reporting of results under minimal supervision when necessary.  This individual will also ensure laboratory instruments and equipment are used properly, as well as maintenance and calibrations are up to date.  The Scientist III will author, and may 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 Scientist III may also serve as technical lead for one or more projects, which may require interaction with clients, and/or other external collaborators or sponsors, while also meeting project goals and timelines.  This role may include supervision of junior level team members as assigned.

RESPONSIBILITIES

  • Author, and assist with, the preparation of a variety of documentation.

  • Interface with, and train QC personnel during transfer/qualification activities.

  • 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, and clientele.

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

  • Adept at gathering and organizing data and information

  • Skilled 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.

  • Maintain mammalian tissue cultures.

  • Expert foundation in experimental design and ability to execute experiments as directed.

  • 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 desired.

  • All other duties as assigned.

QUALIFICATIONS

  • Ph.D. in a related field, with 2 years relevant experience.

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