Principal Scientist, Viral Vector Process Development
Bedford, MA
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.
On April 3, 2024, we announced closure of a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management. Proceeds from the financing will advance Obsidian's lead program in its ongoing trials. We're focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.
Our Opportunity
We're looking for a highly motivated, collaborative, and experienced scientist with a strong background in viral vector process development and a flexible and creative mindset to help drive the development of our cell therapy products targeting cancer. The successful candidate will lead efforts in late-stage process development including process characterization. As part of our Technical Operations team, you will 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.
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 will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
You Will
- Drive the design and execution of experiments for the late-stage development of the cGMP manufacturing process and associated process controls for clinical/commercial supply of viral vectors and associated cell lines/banks.
- Plan, design, execute, and analyze process characterization studies to define critical process parameters and critical quality attributes utilizing statistical design of experiments (DOE) to evaluate process robustness and establish control strategies.
- Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions.
- Manage and mentor a team of scientists and engineers fostering professional development and technical growth.
- Innovate solutions to address current technical challenges and evaluate/ incorporate next-generation process technologies.
- Lead and support key technology transfer document preparation, technology transfer & implementation of the process, and serve as the technical point of contact for the process development function in assigned projects. Occasional travel will be required.
- Supply development viral vector materials to support research/non-clinical studies, analytical development, and CDMO technology transfer activities.
- Represent process development in CMC sub-teams for assigned projects.
- Author relevant CMC sections in regulatory documents and support responses for regulatory agencies.
- Collaborate closely with internal stakeholders (Analytical Development, Quality Control, Research, Quality Assurance, Regulatory, Project Management) in a fast-paced, rapidly developing environment.
You Bring
Core Qualifications
- PhD. in a relevant discipline (chemical or biochemical engineering or related field) and 7+ years relevant industry experience, or MS and 12+ years of relevant industry experience (including at least 2 year in cell or gene therapy) with a progressive track record of leadership and impact.
- Subject matter expertise in mammalian cell culture, particularly adherent cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, and cell biology/physiology.
- Subject matter expertise in downstream lentiviral and/or retroviral vector processing (e.g. TFF, UF/DF, filtration).
- Process Development experience supporting late-stage development of viral vectors inclusive of process characterization.
- Familiarity with QbD Design, design of experiment (DOE), FMEA, process justification, residual testing studies and justification.
- Strong skills in statistical data analysis, including data graphing and trending, correlation search, comparability analyses, statistical design of experiments, and familiarity with software such as JMP and Prism.
- Demonstrated success in technology transfer to CDMOs and technical oversight of external manufacturing during tech transfer.
- Strong organization and record-keeping skills, including an ability to manage multiple responsibilities in parallel.
- A highly collaborative working style - you build trusting relationships, invite and share ideas and feedback, productively challenge your own and others' assumptions to generate new ideas and facilitate better outcomes.
- Willingness and ability to adapt to changes in priorities in a fast-paced, rapidly developing environment to advance our mission.
- Scientific curiosity, and a track record of self-directed learning.
- Self-motivation and a proven ability to work with general direction, exercise good judgement, and seek the information and support you need to meet objectives and timelines.
- Proven ability to manage matrixed projects and tasks to completion, anticipating and elevating risks and obstacles, and adjusting to effective contingency plans.
- A track record of successful performance in a matrixed team environment.
Bonus Qualifications
- Hands-on experience with product characterization methods relevant to viral vector and ancillary materials (e.g. HPLC, SEC, ELISA, Flow cytometry, etc.).
- Knowledge of FDA and EMA guidance relevant to gene and cell therapy.
- Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities.
- Strong working knowledge of cGMP and Quality systems requirements.
Please no agency solicitation.
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.