Scientist I, Analytical Development

Job Code:




The key responsibilities of this role will be to help develop, transfer, optimize and qualify/validate test methods for client projects.  The Scientist I will be required to have practical experience with one or more analytical methods, preferably 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.  This role will also be responsible for maintaining mammalian tissue cultures.

This position will assist with or perform assigned analytical procedures, related testing, data organization, interpretation and reporting of results under general supervision.  This individual will also ensure laboratory instruments and equipment are used properly, as well as maintenance and calibrations are up to date.  The Scientist I may author and/or 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 I may also assist with, or 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.


  • Assist with the preparation of a variety of documents.

  • Interface with, and train, QC personnel during transfer and 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 general supervision, without compromising quality.

  • Maintain professionalism with management, personnel, and clientele.

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

  • Ability to gather and organize data and information.

  • Basic 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.

  • Basic knowledge of cGMP, ICH guidelines, and biological safety is desired.

  • Maintain mammalian tissue cultures.

  • All other duties as assigned.


  • Ph.D. in a related field

  • M.S. in a related field, with 4 years relevant experience