About Us…
Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. We are investigating OBX-115 and enrolling patients in an ongoing multicenter clinical trial in advanced melanoma and non-small cell lung cancer (Agni-01).
We’re proud of our diverse talented team and committed to cultivating an environment 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 facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
In April 2024, we announced closure of an oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors to advance Obsidian’s lead program in its ongoing trials.
Our Opportunity…
The Senior/Principal Scientist, Viral Vector Analytical Development is a key role within our Technical Operations group. We’re looking for an exceptional scientist with expertise in viral vector analytical development to contribute to building Obsidian’s capabilities for process and product characterization. You’ll work closely with the Analytical Development team as well as Quality Control, MSAT, and Process Development to develop and improve analytical tools for the characterization of viral vectors and associated cell therapy products. You’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.
This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, 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.
You Will…
- Apply your expertise in developing, transferring, qualifying and validating analytical assays for viral vectors (retrovirus/lentivirus) to support the release and characterization of viral vectors for cell therapies in all phases of clinical development.
- Design, plan, and execute experiments in Viral Vector Analytical Development, working both independently and as part of a multidisciplinary team of researchers, including partnering closely with the Quality Control and Process Development teams. Collaborate effectively with external stakeholders including: partners and CDMOs/CTLs for establishment, qualification and validation of analytical methods to support manufacturing of viral vectors.
- Apply expertise and provide technical leadership to the team to develop robust assays and support the qualification of assays that assess identity, purity, safety, and potency of viral vectors (e.g., retroviral vectors) and engineered cell therapies.
- Facilitate technology transfer of assays to CDMO partners including training partners and support troubleshooting.
- Work closely with junior scientists to enable their success in the lab and support professional development including mentoring on experiment design, data analysis with appropriate scientific rigor, and proper documentation in lab notebooks.
- Support introduction of new analytical technologies, analytical equipment, implementation of common reagents and controls and trending of data.
- Author and review technical and scientific documents including study protocols and reports, validation documents, SOPs, and test methods.
- Act as subject matter expert in viral vector analytical development. Represent the Analytical Development function as needed for regulatory interaction and author relevant CMC sections in regulatory documents.
- Travel may be required to support on-site person in plant for method transfer and qualification at testing facilities. (<10%)
You Bring….
Core Qualifications
- Ph.D. in a relevant discipline (molecular biology, immunology, biochemistry, cell biology, virology or related field) with a minimum of 3+ years, or MS and 8+ years relevant industry experience.
- Hands-on experience in retroviral and/or lentiviral vector analytical development with a progressive track record of supporting internal/external testing of vector lots and leading the communication of results to the broader team.
- Demonstrable experience with analytical development and method qualification/validation supporting early and/or late-stage development of viral vectors for cell and/ or gene therapy.
- Subject matter expertise in product characterization methods relevant to viral vector (including cell-based vector potency assays, infectious titer, titration assays, PCR / qPCR, ddPCR, sequencing, ELISA, MSD, and western blot).
- Strong troubleshooting skills.
- Experience working with Viral Vector CDMOs/ CTLs for method transfer, development, qualification and validation.
- Working knowledge of cGMP and quality systems requirements.
- Highly organized and able to manage multiple responsibilities in parallel with minimal direction.
- A track record of delivering critical goals while adapting to changing priorities.
- A growth mindset and commitment to high standards. You invite and deliver constructive feedback and exchange ideas with colleagues.
- A desire and ability to work in an entrepreneurial, collaborative environment building healthy, productive, and high trust relationships within your function and with direct stakeholders.
- Strong record-keeping skills.
- Excellent oral and written communication skills.
Bonus Qualifications
- Analytical development and method qualification/ validation for characterization of engineered cell therapies.
- Experience with cell line/ primary cell transduction/ transfection, cytotoxicity assays, Next Generation Sequencing.
- Application of Design of Experiment (DOE) approaches to analytical development.
Job level (Senior or Principal Scientist) will be determined based on overall skillset and experience according to Obsidian’s job level criteria.
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.
