Scientist II/ Senior Scientist, Analytical Development
- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Unum Therapeutics is a clinical-stage biopharmaceutical company focused on developing curative cell therapies to treat a broad range of cancer patients. Unum’s novel proprietary technologies include Antibody-Coupled T cell Receptor (ACTR), an autologous engineered T-cell therapy that combines the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses, and Bolt-On Chimeric Receptor (BOXR), designed to improve the functionality of engineered T cells by incorporating a “bolt-on” transgene to overcome resistance of the solid tumor microenvironment to T cell attack. Unum has multiple programs in Phase 1 clinical testing and preclinical testing, including; ACTR707 used in combination with trastuzumab in adult patients with HER2+ advanced cancer and used in combination with rituximab in adult patients with r/r NHL; and BOXR1030 expressing the GOT2 transgene and targeting GPC3+ solid tumor cancers.
Unum’s BOXR1030, the first preclinical product candidate to emerge from the BOXR platform, is composed of a GPC3 targeted CAR and a “bolt-on” enzyme called glutamic-oxaloacetic transaminase 2 (GOT2) that aims to improve T cell function in the solid tumor microenvironment through enhanced metabolism. GOT2 plays a central metabolic role by linking multiple pathways involved in biosynthesis and cellular energy production.
Unum Therapeutics is headquartered in Cambridge, MA.
As a member of our Analytical Sciences team within the Technical Operations organization at Unum Therapeutics, this collaborative and driven scientist will develop and use state-of-the art analytical methods to support process development, formulation development and characterization of products. The successful candidate will critically evaluate scientific data and study protocols, will lead initiatives, and take part in, and lead cross-functional teams. In addition, this individual will be accountable for ensuring that analytical methods and data are fit-for-purpose.
- Serve as subject matter expert for analytical techniques necessary to advance clinical development including flow cytometry, functional cell-based assays and immunoassays on multi-functional product and program teams.
- Evaluate and develop fit-for-use analytical methods for the measurement of quality attributes of T-cell therapy products, in-process intermediates and viral vector.
- Mentor and/or manage junior scientists in development of analytical test methods and characterization activities to support Unum’s pipeline within established timelines while ensuring data quality and integrity.
- Serve as technical expert for cross-site method development, technology transfer and qualification activities and provide technical support to external vendors as required.
- Participate in design and execution of experiments and complete laboratory testing.
- Follow good documentation and review practices, and effectively communicate scientific results and strategies in presentations and written reports
- Draft technical reports, standard operating procedures and test protocols in support of analytical development.
- Maintain knowledge of and critically evaluate scientific literature and industry trends in order to contribute maximally to Unum’s development efforts.
- The Scientist will be an expert in flow cytometry and cell-based assays as well as one or more of the following techniques: cellular imaging, immunoassay such as MSD, ELISA, HTRF, or qPCR.
- Analyze samples and document analytical results in a regulatory compliant manner under minimal supervision
- PhD in the biological sciences with minimum of 3 years, MS with 8 years or BS with 10+ years’ experience in development of bioanalytical methods
- Expertise in Cellular biology or Immunology with mastery of functional characterization, flow cytometry and cell-based assay development is required.
- Previous experience in the biopharmaceuticals industry or in cell therapy is required.
- Experience in T-cell biology and immunophenotyping is strongly preferred.
- Experience with bioanalytical techniques such as ELISA, MSD, cytometric bead array, ELISpot and cell imaging is highly desired.
- Excellent oral and written communication skills and ability to document, organize, and present experimental data, conclusions and other information, including recommendations in a clear, concise and logical manner within function are required
- In-depth working knowledge of ICH Guidelines for Bioanalytical method validation is preferred.
- Experience with quality systems and electronic lab notebooks is desirable
- Proficiency with data analysis tools such as FlowJo, FACSDiva, GraphPad Prism, Softmax, Stat-Ease Design-Expert , and JMP software is desirable
All your information will be kept confidential according to EEO guidelines.