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Analytical Scientist I-II, Cell Therapy

Company: Immunomic Therapeutics, Inc.
Location: Rockville
Posted on: September 16, 2022

Job Description:

Analytical Scientist I-II, Cell Therapy

Job Code: 2022 CT005

Job Description

Immunomic Therapeutics, Inc. (ITI), a privately held, pre-IPO clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy using UNITE---. Powered by LAMP (Lysosomal Associated Membrane Protein), ITI's UNITE platform is designed to utilize the body's natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE--- platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases. ITI is primarily focused on applying the UNITE platform in oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The company has built a pipeline of four wholly owned oncology programs, the lead of which is in a Phase 2 clinical study for Glioblastoma Multiforme (GBM).

The Analytical Scientist, Cell Therapy Operations will be responsible for 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. The successful candidate will have competency in the application of statistical methods, tools for data analysis, writing technical reports, and data presentation in internal and external meetings. The candidate will report to the Associate Director, Cell Therapy Operations.

Essential Functions

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, cell culture/cell-based bioassays etc.
Independently design, plan, and execute analytical method development as a SME for flow cytometry assays using Quality by Design (QbD) and design of experiment (DOE) approaches.
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

Competencies and Skills

Customer Focus
Communication/Presentation Skills (spoken, written)
Sense of Urgency
Collaboration Skills

Required Education and Experience

Scientist I: Ph.D. in appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 1-3 years of work experience (Scientist I) preferably in cell therapy.
Scientist II: Ph.D. in appropriate discipline (e.g., molecular biology, biochemistry, immunology) with 3-5 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 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.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Please visit our careers site at Send your cover letter and credentials as described on the Careers page along with the Job Code: 2022 CT005 in the subject line.

Equal Opportunity Employer

Keywords: Immunomic Therapeutics, Inc., Rockville , Analytical Scientist I-II, Cell Therapy, Healthcare , Rockville, Maryland

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