Senior Scientist, Analytical Development
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety.
Located in the heart of Cambridge, we’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options.
We’re looking for a leader in analytical development to contribute to building Obsidian’s analytical sciences capabilities for process and product characterization, driving the development of the first autologous cell therapy product in our pipeline targeting cancer. This is a key role, focusing on molecular and immunological assay development. You’ll work collaboratively with the Analytical Development team as well as Manufacturing, Process Development, Regulatory, and Quality functions to develop analytical tools for the characterization of viral vectors and cell therapy products to support our clinical pipeline. As part of our Technical Development and Manufacturing department, you’ll be a vital part of working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients, , starting with our lead program cytoTIL15 engineered to make TILs more effective for more patients.
This is a unique opportunity in a well-funded early-stage company with blue-chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
- Apply your expertise in developing and qualifying analytical assays to support the release and characterization of viral vector and cell therapy products in early and later phases of development.
- Design, plan, and execute experiments in Analytical Development, working both independently and as part of a multidisciplinary team of researchers
- Support method development and provide technical expertise for the qualification of assays to assess identity, purity, safety and potency in engineered primary cells (eg TIL, T Cell, NK cell) and viral vectors (eg lentiviral vectors)
- Support introduction of new analytical technologies, implementation of common reagents and controls, trending of data, and generation of SOPs to support vector production, and transfer of analytical methods to CDMOs
- Interpret results, troubleshoot technical hurdles, and propose solutions to the team
- Maintain excellent records of experiments, including Electronic Notebook entries.
- Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods
- Help build the team and mentor/train team members on experiment design, data analysis with adequate scientific rigor and proper documentation in lab notebooks and reports
- Collaborate effectively across Obsidian organization, present internally to project teams, management, and scientific teams.
- Represent analytical development in CMC sub-teams for assigned projects and support project activities including authoring of relevant CMC sections in regulatory documents
- Ph.D. in a relevant discipline (immunology, biochemistry, cell biology, biotechnology or related field) and 3+ years relevant industry experience. or MS and 10+ years of relevant industry experience.
- Prior direct experience in viral vectors or cell therapy
- Demonstrated track record with analytical development supporting early and/or late-stage development of biologics
- Subject matter expertise in product characterization methods relevant to an immune cell-based product and viral vector starting materials, with a focus on molecular and immunoassay development (PCR / qPCR, ddPCR, ELISA, MSD and western blot)
- Strong troubleshooting and communication skills, highly organized with strong record-keeping and an ability to multi-task
- Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment
- Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission
- Demonstrated track record with analytical development and method qualification for characterization of engineered cell therapies or viral vectors
- Experience with multi-parameter flow cytometry assays, cell line/ primary cell transduction/ transfection, and cell-based assay development
- Experience with Design of Experiment (DOE) approaches and application to analytical development
- Experience working with CDMOs/ CTLs for method transfer/ development/ qualification/ validation
- Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.