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Salary: USD 81,000 - 99,000 / annual
Obsidian Therapeutics is seeking a Senior Engineer, MSAT to support manufacturing of critical materials for engineered autologous cell therapies. This role serves as the technical bridge between development and external manufacturing partners (CDMOs) for retroviral vector and feeder cell processes, ensuring processes are understood, controlled, reproducible, comparable, validated, and technically defensible for regulatory approval.
As a member of the Technical Operations Group, you will work on the company's lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy using the proprietary cytoDRiVE® platform currently in clinical development for metastatic melanoma and non-small cell lung cancer.
Core responsibilities include:
- Serve as a technical contributor and developing Subject Matter Expert (SME) for gamma-retroviral vector and feeder cell manufacturing, working closely with cross-functional teams
- Lead and support technology transfer workstreams to CDMOs, including transfer of process knowledge, critical process parameters, control strategy elements, methods, and manufacturing documentation
- Serve as Person-in-Plant (PIP) at CDMO facilities as needed to support training, technology transfer, investigations, process monitoring, and execution of critical manufacturing activities
- Develop effective working relationships with CDMO technical and manufacturing teams
- Analyze manufacturing and process-monitoring data, identify trends and atypical observations, and work with senior scientists/engineers and cross-functional SMEs to establish scientific understanding
- Support change controls, process improvements, and validation activities by providing technical assessments and process knowledge
- Lead and support technical investigations for deviations, process excursions, atypical results, and manufacturing failures in partnership with Manufacturing Process Development, Quality, and CDMOs
- Leverage process knowledge and analytical data to support root-cause investigations and development of corrective or preventive actions
- Support process validation and PPQ readiness and execution, including protocol development/review, manufacturing readiness assessment, and on-site technical support
- Develop and maintain FMEAs to evaluate process risks and contribute to development and implementation of manufacturing control strategy
- Author and review protocols, technical reports, investigations, risk assessments, validation-support documentation, and relevant portions of CMC regulatory documentation
- Support establishment of post-approval process monitoring and lifecycle-management activities
This is a hybrid role based in Bedford, MA, requiring travel up to 25–30% to support CDMO activities and occasional after-hours or weekend oversight of ongoing manufacturing runs.
Qualifications:
- M.S. or B.S. in Chemical Engineering, Bioengineering, Biotechnology, Cell Biology, Virology, Immunology, Biochemistry, or a related scientific discipline
- 10+ years of relevant biopharmaceutical industry experience in MSAT, Process Development, Viral Vector Development, Cell Therapy, Gene Therapy, or related manufacturing sciences
- Technical expertise in viral vector manufacturing, preferably gamma-retroviral vector production using stable producer cell lines and adherent cell culture systems
- Strong understanding of aseptic processing and cGMP requirements, and their application to viral vector and mammalian cell culture manufacturing
- Demonstrated experience supporting PPQ, process validation, regulatory submissions, and commercialization readiness
- Experience developing FMEAs and process risk assessments (SIPOC, HAZOP) and root cause analysis (fishbone/Ishikawa); familiarity with feeder cell manufacturing is highly desirable
- Extensive experience analyzing and interpreting manufacturing process data using statistical software such as JMP or Minitab
- Scientific rigor to enable data-driven decisions
- Experience managing CDMOs
Bonus qualifications:
- Prior experience working with TIL or T cells
- Prior experience supporting first commercial launch
