Role Purpose:

The role of the Senior Scientist is to serve in an advanced technical role in the Analytical Development laboratory to delivery cell and gene therapy programs. The key responsibilities of this role will be to develop, transfer, optimize and qualify/validate test methods for client projects. The Senior Scientist 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 Senior Scientist 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 Senior Scientist 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 and training 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 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, organize, and analyze data and information skillfully.
• Strong foundation in experimental design and ability to execute and troubleshoot complex experiments.
• Must be able to communicate effectively through oral and written means.
• Well organized with effective time management and attention to detail.
• Working knowledge or cGMP, ICH guidelines, and biological safety.
• Ensure personnel are properly trained in the use of laboratory equipment and instrumentation.
• Advanced knowledge of cGMP, ICH guidelines, and biological safety is desired.
• All other duties as assigned.
• Author a variety of documents, ranging from SOPs, and transfer protocols, to qualification reports. Perform method establishment/transfer/development/optimization and qualification/validation. Analyze, organize, and report data from experimental and laboratory activities. Interface with, and train, QC personnel during transfer and qualification activities. Troubleshoot failed assays, and assist in resolving instrumentation issues, as well as OOS, and OOT scenarios.

Qualifications:

• PhD or MS In Virology, Biochemistry or related field. B.S. considered with aligned experience level.
• Ph.D. with a minimum of 3 years of relevant experience.
• M.S. degree with a minimum of 6 years of relevant experience.