Scientist II, Analytical Development

Job Code:

P1075

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JOB DESCRIPTION

The key responsibilities of this role will be to help develop, transfer, optimize and qualify/validate test methods for client projects.  The Scientist II will be required to have intermediate practical experience with multiple 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 and/or perform assigned analytical procedures, related testing, data organization, interpretation and reporting of results under limited 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 II may author and/or review standard operating procedures (SOPs), Test Methods, Qualification and Validation protocols, and reports. 

The ideal candidate will be capable of thriving in a matrix environment, regularly interfacing with personnel in QC, QA, PD, and other departments.  The Scientist II 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. 

RESPONSIBILITIES

  • Author and/or 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 limited 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.

  • Advanced 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.

QUALIFICATIONS

  • Ph.D. in a related field, with 1 year relevant experience.

  • M.S. in a related field, with 5 years relevant experience.