Senior MSAT Engineer, Gene Therapy Tech Transfer & CDMO

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

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,