Senior MSAT Engineer – Viral Vector Manufacturing

Obsidian Therapeutics, Inc.; Bedford (MA); Hybrid; USD 158,000 - 193,000; Full time

Benefits offered by this job

Stock options

Annual performance bonus

Health insurance

Job summary

Obsidian Therapeutics, Inc. is seeking a Senior Engineer, MSAT to bridge development and external manufacturing for retroviral vector and feeder cell processes.

You will ensure processes are well understood, controlled, and defensible for regulatory approval, driving risk assessments and cross-functional collaborations. The role involves travel up to 25–30% to support CDMO activities, with a hybrid work arrangement at Bedford, MA, and strong emphasis on data-driven decisions, process validation,

Qualifications

• MSAT/engineering experience in biopharmaceutical manufacturing and cell therapy
• Strong cGMP knowledge and regulatory experience (PPQ, validation)
• Experience with risk assessments and FMEAs
• Familiarity with CDMOs and tech transfer processes
• Data-driven decision making and statistical analysis

Responsibilities

• Serve as SME for gamma-retroviral vector and feeder cell manufacturing activities.
• Lead tech transfer to CDMOs and document control strategies and CPs.
• Act as PIP at CDMO sites for training and investigations.
• Collaborate with PD, QA, and External Manufacturing to support investigations.
• Support process validation, PPQ readiness, and regulatory documentation.
• Develop and maintain FMEAs and risk controls.
• Review protocols and risk assessments for regulatory submissions.
• Monitor manufacturing performance and support lifecycle management.

Skills

MSAT

Viral vector manufacturing

Process development

cGMP

PPQ readiness

FMEAs

Risk assessments

CDMO management

Statistical analysis

Technical writing

Education

M.S./B.S. in Chemical Engineering

Biotechnology/related science

Related scientific discipline

Tools

JMP

Minitab

Job description

Obsidian Therapeutics, Inc. is seeking a Senior Engineer, MSAT to bridge development and external manufacturing for retroviral vector and feeder cell processes.

You will ensure processes are well understood, controlled, and defensible for regulatory approval, driving risk assessments and cross-functional collaborations. The role involves travel up to 25–30% to support CDMO activities, with a hybrid work arrangement at Bedford, MA, and strong emphasis on data-driven decisions, process validation,