Scientist II, Flow Cytometry Assays, Cell Therapy Franchise

Employer
Resilience
Location
Bedford, MA
Posted
Jun 30, 2022
Ref
R-100565
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time

Resilience is seeking a highly motivated Scientist II, Flow Cytometry Assays to join Cell Therapy Franchise in Analytical Development. The successful candidate will take the lead on the development of flow cytometry assays and documenting Resilience’s cell therapy testing solutions.

As a scientist on the flow cytometry assay team, you will:

  • Initiate, direct, and execute the development and optimization of flow cytometry/CyTOF/immunophenotyping to support the cell therapy franchise, with a focus on the cellular phenotypic characteristics of drug substances and drug products that correlate to patient outcomes.

  • Explore state of the art technology platforms and disruptive approaches to existing flow cytometry assay platforms.

  • Collaborate with analytical and QC groups to develop best practices at multiple sites of clinical manufacturing for cell therapyand to further enhance a center of analytical excellence for Resilience's global cell therapy product portfolio.​

  • Establish Resilience as a leader in cell therapy analytical science through the development and application of processes, procedures and technologies for best-in-class testing strategies.

Job Responsibilities

  • Apply expertise in immunology, flow cytometry, cell biology, biochemistry, and/or molecular biology to analytical design and development of new methods for product characterization and product release.

  • Plan and execute analytical flow cytometry assay activities including laboratory research, development, and qualification/validation of analytical methods for cell therapy candidate testing, process development, comparability, and technology transfer.

  • Design and develop protocols and reports for novel assays and serve as an analytical subject matter expert to solve technical challenges and support laboratory investigations.

  • Lead the technology transfer of analytical methods to QC and serve as a subject matter experience to support analytical validation, process transfer and potential troubleshooting as necessary.

  • Generate reference standards, support sample and critical reagents tracking for flow cytometry lab.

  • Support continuous improvement of processes and provide analytical characterization support in all related operating units within the Resilience organization and with external groups.

  • Maintain and enhance current knowledge of emerging Molecular technologies in the field of analytics, bioanalytics, and translational/biomarkers to support improvements for existing analytical strategies.

Qualifications

  • MS with 5 years of relevant industry experience or PhD with 3 years of relevant industry experience in immunology, cell biology, cell engineering, pharmacology, pharmaceutical sciences, or a closely related field.

  • Experience designing and developing flow cytometry, immunological and/or biochemical assays for immune cell phenotyping.

  • Experience in applying scientific principles and concepts to potential innovative platforms and disruptive technologies.

  • A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a regulatory environment.

Preferred Experience

  • Experience working with human immune cells and/or hematopoietic stem/progenitor cells.

  • Experience with analysis of complex cell populations using Flow cytometry and CyTOF.

  • Experience with high throughput assay formats using state of the art technologies and automation.

  • Experience developing advanced platforms for cell characterization, cell activation, cell signaling assessment.

  • Experience in method qualification/validation.

  • Experience with various cell immunophenotyping analysis platforms for product characterization of cell therapy products.

  • Experience with analytical or statistical software, e.g. GraphPad Prism, Softmax Pro, Gen5, Sigma XL, etc.

  • GxP experience (GDP, equipment qualification, and/or LIMS).

  • Knowledge of cGMP pertaining to the pharmaceutical and biological industries.

Other Ideal Personal Characteristics

  • Hungry, humble, and a learning machine with an open, inquisitive mind regarding the future of medicine and biomanufacturing.

  • Embodies the Resilience phenotypes of grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership.

  • Smart, curious, flexible, able to contribute at a very high level, as well as possessing a hands-on manner, when necessary.

  • Collaborative style, with an ability to build consensus among both internal and external stakeholders.

  • A person of unquestioned integrity and moral character; an individual that others can trust without reservation.