Job Summary:
The Senior Scientist, Analytical Sciences is responsible to develop and qualify cell-based analytical methods and evaluate new analytical technologies. Also responsible to author and review method development reports, test methods, SOPs, protocols, supporting the technical review of CMC sections and supporting documents for regulatory filings. Must have industry experience in the development, qualification, and validation of cell bioassays (ELISA, Flow Cytometry, etc.) including experience with scale-up of methods to commercialization. Leads the collection and interpretation of data for biomarker and biological characterization assays including cell-based, multiplexed protein assays, and flow cytometry methods. Will work with manufacturing and quality control to develop tests, as well as analyze and author reports. Prepares technical reports, summaries, protocols and quantitative analyses.
This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the company's Values.
Essential Duties and Responsibilities:
- Manage strategic, SME, technical, and scientific development related to biological assays and other critical analytical methods.
- Advance and implement cell-based bioassay/potency and immunophenotyping by multi-parametric flow cytometry methods from conception through optimization, qualification, and method transfer to Quality Control and external partners as part of an analytical control strategy and to support Process Development.
- Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
- Work with Process Development, implementing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms.
- Work with Quality partners to draft study protocols, qualification reports, change controls, and occasionally perform routine assays as QC personnel for drug product release and characterization.
- Write, review, and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms.
- Provide technical guidance to junior staff, assign tasks, review data, and strengthen regulatory concepts (cGMP).
- Participate in group and department meetings, present scientific data, and provide expertise in areas of responsibility.
- Maintain, calibrate, and operate analytical equipment and instrumentation that is used in the execution of assays.
- Author quality records (change controls, deviations, investigations) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA.
- Author/contribute to other technical reports, including but not limited to comparability protocols/reports, risk assessments, and justification of specification, etc.
- Others duties as required.
