Senior Engineer, MSAT

obsidiantherapeutics; Bedford (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Obsidian Therapeutics is seeking a highly motivated Senior Engineer, MSAT to support manufacturing of critical materials for our engineered autologous cell therapies. This role will bridge development and external manufacturing for the retroviral vector and feeder cell process, ensuring CDMOs are understood, controlled, reproducible, and ready for regulatory approval.

You will lead tech transfer, risk assessments, operating ranges, and control strategies, partnering with Process Development,

Qualifications

• Must have experience with gamma-retroviral vector and feeder cell manufacturing.
• Experience leading technology transfer to CDMOs.
• Ability to perform risk assessments and develop control strategies.
• FMEAs and process validation knowledge.
• Strong cross-functional collaboration and data analysis.

Responsibilities

• Serve as SME for gamma-retroviral vector and feeder cell manufacturing.
• Lead technology transfer of processes to CDMOs and ensure reproducible execution.
• Act as PIP at CDMO facilities to support training, investigations and monitoring.
• Develop effective working relationships with CDMO teams.
• Analyze manufacturing data to identify trends and root causes; collaborate with SMEs.
• Support change controls, process improvements and validation activities.
• Lead investigations for deviations and excursions in partnership with CDMOs and QA.
• Support PPQ readiness and on-site technical support.
• Develop and maintain FMEAs for process risks.
• Author/review protocols, reports, risk assessments, and CMC docs.

Skills

gamma-retroviral vector

feeder cell manuf.

technology transfer

PIP

cross-functional collaboration

data analysis

root-cause investigations

regulatory readiness

FMEAs

process validation

Job description

About Us

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian's programs apply our cytoDRiVE® 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 for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

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 Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity

We are seeking a highly motivated Senior Engineer, MSAT to support manufacturing of critical materials for our engineered autologous cell therapies. This role will serve as the technical bridge between development and external manufacturing for the retroviral vector and feeder cell process, responsible for ensuring that the processes run by CDMOs are sufficiently understood, controlled, reproducible, comparable, validated, and technically defensible for regulatory approval.

This hire will oversee technology transfer, drive risk assessments, operating ranges, and control strategies. They will lead cross-functional efforts with Process Development, Analytical Development, Quality, External Manufacturing, and external CDMO partners to support manufacturing investigations and ensure readiness for PPQ and future commercial manufacturing.

As a member of our Technical Operations Group, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field‑leading advisors, best‑in‑class partners, and an experienced team.

This is a Hybrid role based out of our Bedford, MA location, requiring travel up to 25-30% to support CDMO activities and occasional after-hours or weekend oversight of ongoing manufacturing runs as needed.

You Will

Core responsibilities

• Serve as a technical contributor and developing Subject Matter Expert (SME) for gamma-retroviral vector and feeder cell manufacturing activities supporting production of OBX-115, working closely with cross-functional teams.
• Support and lead defined workstreams for technology transfer of manufacturing processes to CDMOs, including transfer of process knowledge, critical process parameters, control strategy elements, methods, and manufacturing documentation. Partner with Scientists or Engineers to ensure successful and reproducible execution at receiving sites.
• Serve as Person-in-Plant (PIP), as needed, at CDMO facilities 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 the Principal /Senior Scientists or Engineers and cross-functional SMEs to establish scientific understanding and appropriate follow-up.
• Support change controls, process improvements and validation activities by providing technical assessments and process knowledge.
• Lead and support technical investigations, as appropriate, 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 scientifically sound root-cause investigations and development of appropriate corrective or preventive actions.
• Support process validation and PPQ readiness and execution, including development/review of protocols, assessment of manufacturing readiness, evaluation of process performance, and on-site technical support.
• Develop and maintain FMEAs to evaluate process risks and contribute to development and implementation of the manufacturing control strategy, translating process-characterization and manufacturing knowledge into appropriate process controls, monitoring approaches, and risk-management activities.
• 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, including continued process verification, t