Director, MSAT – Cell Therapy Manufacturing Leader

Obsidian Therapeutics, Inc.; Bedford (MA); Hybrid; USD 219,000 - 268,000; Full time

Benefits offered by this job

Stock options

Annual incentive bonus

Medical, dental, and vision coverage

Generous PTO

Job summary

Obsidian Therapeutics, Inc. seeks a Director, MSAT in Bedford, MA to lead end-to-end manufacturing sciences and technology for our autologous cell therapy programs, including OBX-115. You will be the technical anchor across process development, manufacturing, quality, and external partners.

The role focuses on PPQ readiness, process validation, and lifecycle management, driving data‑driven decisions, risk mitigation, and regulatory readiness for BLA submissions, with domestic travel up to ~30%.

Qualifications

• PhD/MS/BS in Chemical Engineering, Bioprocessing, or related field.
• 15+ years in drug development with 5+ leading MSAT teams for autologous therapies.
• Autologous cell therapy experience and GMP/CDMO exposure.

Responsibilities

• Lead MSAT strategy from late-stage development to lifecycle management.
• Oversee PPQ readiness and batch record approvals.
• Interface with CDMOs, QA, Process Development, and Regulatory for regulatory submissions.
• Drive risk management with SIPOC, FMEA, and HAZOP.
• Prepare for PAI and FDA inspections.

Skills

MSAT leadership

Autologous cell therapy

Data‑driven decisions

FDA/CMC knowledge

Statistical analysis

Risk assessments

CPP/CQA knowledge

GMP/CDMO oversight

Education

PhD/MS/BS in relevant field

Tools

JMP

Minitab

Job description

Obsidian Therapeutics, Inc. seeks a Director, MSAT in Bedford, MA to lead end-to-end manufacturing sciences and technology for our autologous cell therapy programs, including OBX-115. You will be the technical anchor across process development, manufacturing, quality, and external partners.

The role focuses on PPQ readiness, process validation, and lifecycle management, driving data‑driven decisions, risk mitigation, and regulatory readiness for BLA submissions, with domestic travel up to ~30%.