Principal 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. Obsidian’s lead program is currently in clinical development. We recently received our IND clearance from FDA to begin our first clinical trial for the treatment of patients with metastatic melanoma.
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. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our brand new facility in Bedford, MA to support our growth. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
The Principal Scientist, Analytical Development is a key role within our Technical Development and Manufacturing group and will be responsible for leading a team within Analytical Development. We’re looking for a leader 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. 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 to be a contributor in a well-funded pre-clinical company with blue chip investors, field-leading advisors, best-in-class partners (BMS, Vertex, MD Anderson), and an experienced team. You'll 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, transferring, qualifying and validating analytical assays to support the release and characterization of engineered cell therapy products in early and later phases of development, with a focus on characterization of the retroviral and/ or lentiviral vectors.
- Provide and apply technical expertise to the team to develop, qualify and facilitate technology transfer of assays to assess identity, purity, safety and potency of viral vectors (e.g., retroviral vectors) and engineered cell therapies.
- Work closely with junior scientists to support their career growth and success in the lab, including mentoring on experiment design, data analysis with appropriate scientific rigor, and proper documentation in lab notebooks.
- Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods.
- Collaborate effectively with process development and establish strong relationships with internal and external stakeholders, including research, CMC team, partners and CDMOs/CTLs for establishment, qualification and validation of analytical methods to support development.
- Act as subject matter expert and represent the analytical development function as needed for regulatory interaction and author relevant CMC sections in regulatory documents.
- Provide technical support to internal and external analytical operations.
- Source and evaluate new equipment and technologies to expand and build internal technical capabilities.
- PhD in a relevant discipline (molecular biology, immunology, biochemistry, cell biology, virology or related field) with a minimum of 5+ years relevant industry experience including prior direct experience in retroviral and/ or lentiviral vector analytical development and a progressive track record of leadership and impact.
- A track record with analytical development and method qualification/validation supporting early and/or late-stage development of biologics (cell therapy, gene therapy, vaccines, antibodies…).
- Subject matter expertise in product characterization methods relevant to viral vector (including cell-based potency assays, titration assays, PCR / qPCR, ddPCR, sequencing, ELISA, MSD, and western blot).
- Strong troubleshooting, organization, and record keeping skills.
- Experience working with CDMOs/ CTLs for method transfer/development/qualification/ validation.
- Strong working knowledge of cGMP and quality systems requirements.
- Ability to manage multiple responsibilities in parallel with minimal direction.
- Prior experience managing functional teams and representing function in CMC teams
- A track record of leading teams to deliver critical goals while adapting to changing priorities.
- A leadership style orientated to high standards and support to succeed and grow. You engage input of team members, encourage open honest dialogue, and empower for ownership and accountability.
- A desire and ability to work in an entrepreneurial, collaborative environment. You build healthy, productive, and high trust relationships within your function and with direct stakeholders, and effectively influence actions and decisions.
- Excellent oral and written communication skills.
- A track record with analytical development and method qualification/ validation for characterization of engineered cell therapies.
- Experience with multi-parameter flow cytometry assays, cell line/ primary cell transduction/ transfection, cytotoxicity assays, Next Generation Sequencing.
- Experience with Design of Experiment (DOE) approaches and application to analytical development.
Job level will be based on overall experience and capabilities
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.