Principal Scientist, Cell Therapy Process 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.
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 and Manufacturing will soon be moving to a 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.
We’re looking for a highly motivated scientist with a strong background in cell therapy and/or process development to help drive the development of multiple cell therapy products in our pipeline targeting cancer. As part of our Technical Development and Manufacturing department you will be a vital part of a highly collaborative team working to achieve the Obsidian’s vision by 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.
- Contribute your expertise and strategic thinking to develop clinical/commercial manufacturing processes, cell therapy products, tech transfer to CDMOs, oversight of external manufacturing, and regulatory filings
- Drive the design and execution of experiments for development of the cGMP manufacturing process and associate process controls for clinical supply of cell therapy product (and related materials) meeting yield and quality targets
- 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 train and mentor team members on experiment design, data analysis with appropriate scientific rigor and proper documentation in lab notebooks
- Innovate solutions to address current technical challenges and evaluate/ incorporate next generation process technologies
- Supply development materials (viral vector, cell product) to support research/non-clinical studies, analytical development, and CDMO tech transfer activities
- 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
- Establish strong relationships and collaborate closely with internal stakeholders (research, quality, regulatory, project management)
- Represent process development in CMC sub-teams for assigned projects and support project activities including authoring of relevant CMC sections in regulatory documents
- PhD and >5 years industry experience in a relevant discipline (chemical engineering, biomolecular engineering, biotechnology or relevant field), or MS and >15 years relevant experience, with a progressive track record of leadership and impact.
- Deep subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology
- Hands-on experience with product characterization methods relevant to cell therapy (e.g. flow cytometry)
- A highly collaborative working style.
- A flexible and creative mindset; able to productively challenge and be challenged to generate the best ideas to advance project and company goals.
- An ability to operate and adapt in a fast paced, rapidly developing environment
- Experience translating high level goals into plans, and independently leading teams to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission
- Successful experience leading and managing high performing matrixed teams
- Prior experience with T-cells, NK cells, induced pluripotent stem cells (iPSC), or other primary cells is a plus.
- Demonstrated track record with process development supporting early and/or late stage development of biologics (cell therapy, gene therapy, vaccines, antibodies…)
- Experience with and technology transfer to CDMOs and external manufacturing oversight
- Familiar with FDA and EMA guidance documents relevant to gene and cell therapy
- Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities
- Experience with Design of Experiment (DOE) approaches and application to process development
- Strong working knowledge of cGMP and quality systems requirements
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.