Analytical Scientist I-II, Cell Therapy

Beyond A Resume

Beyond A Resume is seeking a full-time Analytical Scientist with Cell Therapy experience for our Biotechnology client in Rockville, MD.

Job Description:

The Analytical Scientist, Cell Therapy Operations will be responsible for the development of analytical methods for cell therapy products at ITI. This position requires a highly motivated scientist with proven skills in analytical method development, and the ability to develop new, innovative approaches including experience with new assay technology evaluation and shaping scientific strategy both at the platform and program level. SME in Immunology techniques including Flow cytometry, ELISA, Tetramer analysis, cell culture/cell-based bioassays, etc. are preferred.

Reports to:

Associate Director, Cell Therapy Operations

Job Responsibilities:

-Develop, qualify and tech transfer assays to assess safety, identity, purity, and potency of cell therapies including but not limited to FLOW cytometry, ELISA, Tetramer analysis, cytotoxicity assays, and cell culture/cell-based bioassays, etc.

-Independently design, plan, and execute analytical method development as an SME for flow cytometry assays using Quality by Design (QbD) and design of experiment (DOE) approach.

-Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation.

-Author, review, and edit test methods and SOPs, and supporting documents for regulatory filings.

-Critically analyze data and author technical reports.

-Partner with Research, PD, and QC to identify new technologies and opportunities for continuous improvement in analytical methods.

-Summarize and present data in group meetings and contribute to group discussions.

-Establish the product characterization, lot release, and stability testing panels.

-Will interact directly with R&D, Quality, Regulatory Affairs, and Project Management as an integral part of the product development team.

-May interact with external organizations (e.g., Contract Manufacturing, Contract Testing, Contract Development, Equipment vendors)

-May have direct supervisory responsibilities of Research Associates

Job Requirements:

-Scientist I: Ph.D. in the appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 1+ years of work experience (Scientist I) preferably in cell therapy.

-Scientist II: Ph.D. in the appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 3+ years of work experience preferably in cell therapy.

-Ph.D. requirement may be offset with significant appropriate and directly relevant experience.

-Understanding of immunology and cellular biology with application to the development of analytical methods.

-Experience and competency with the following: multi-color flow cytometry, ELISpot, ELISA, cell culture/cell-based bioassays. Prior experience developing potency and/or immunophenotyping test methods for cellular therapies.

-Experience working with human immune cells is preferable.

-Competency in the application of statistical methods and tools for data analysis.

-Ability to work independently or as a team member to meet goals and commitments.

-Strong written and verbal communication skills are required. Experience translating complex scientific concepts and data into reports, presentations, and CMC filings is required.

-Able to work onsite

*Relocation assistance is available for qualified candidates

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