Director, Manufacturing Science and Technology (MSAT)

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.

The Opportunity

We are looking for a highly motivated Director, MSAT, with a strong background in drug development (preferably autologous cell therapy). You’ll serve as the go-to technical leader for manufacturing operations, solving complex problems and translating data into actionable improvements, helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors. You will lead end-to-end MSAT strategy and execution, ensuring seamless progression from late-stage development through PPQ and lifecycle management.

You Will...

• Serve as the lead MSAT interface to CDMOs, providing technical oversight of clinical manufacturing to ensure consistent production, rapid troubleshooting, and accelerated release of cell therapy drug product, viral vector drug substance, and custom biologic ancillary materials for patients in ongoing trials.
• Manage escalations through joint governance forums and collaborate with Process Development and External Manufacturing to align on technical decisions and execution.
• Define and maintain CPPs, CQAs with CDMOs
• Partner with Process Development and Analytical Development to define process characterization plans, comparability strategy, and lifecycle control approaches.
• Define and implement a comprehensive control strategy ahead of PPQ to enable consistent process performance, assure product quality, and support a successful validation and regulatory outcome
• Own and maintain the integrity of process monitoring databases (CPV, PPQ, and lot history), utilizing statistical tools to monitor process variability, analyze trends, detect shifts, quantify variation, identify signals requiring investigation, and drive data-based insights and decisions.
• Lead manufacturing campaign review processes.
• Define and lead PPQ strategy and execution, ensuring timely and comprehensive PPQ readiness.
• Oversee authoring and review of batch records, validation protocols, and validation/verification reports. Ensure documentation is scientifically rigorous, operationally usable, phase-appropriate, and compliant.
• Drive governance of tech transfer plans, protocols, and reports; and process validation documentation.
• Structure the MSAT team’s technical materials for BLA readiness, ensuring lifecycle validation documentation is pristine.
• Author and/or review relevant CMC sections of regulatory submissions, including the compilation and lock of all scientifically rigorous MSAT reports and relevant data packages. Ensure the technical dossier is fully complete and ready for BLA submission.
• Serve as MSAT subject matter expert in support of FDA interactions, inspection readiness, and PAI execution.
• Serve as the technical lead in complex or consequential process-related manufacturing investigations/deviations, change controls, complaints, and CAPAs.
• Partner with External Manufacturing and Quality to ensure consistent investigation standards and timely, effective remediation across CDMO and internal teams.
• Provide technical leadership for risk management, including facilitating and documenting SIPOC, FMEA, and/or HAZOP to define controls, reduce variability, and mitigate risks.
• Prepare CDMOs and internal teams for PAI, ensuring audit readiness with complete documentation and lifecycle validation materials.
• Align team priorities and focus with company strategy and goals.
• Drive a team culture of high standards, collaboration, transparency, accountability, continuous learning, and trust.

You Bring...

• PhD, MS, or BS in Chemical Engineering, Bioengineering, Biology, or related field
• 15+ years of progressive experience, including at least 5 years successfully leading late stage and/or commercial MSAT team for a novel therapy in an external manufacturing model.
• Autologous cell therapy experience.
• A data driven and detail-oriented mindset, with the ability to drive timely fact-based cross functional analysis and decision making in complex and high consequence scenarios.
• Knowledge of FDA guidance relevant to cell and gene therapy manufacturing, validation, and lifecycle management (EMA is a plus).
• Strong experience in:
• Leading and documenting risk assessments (e.g., SIPOC, FMEA, and/or HAZOP) and root cause analysis methods (e.g., 5-Why, Fishbone/Ishikawa)
• Analyzing and interpreting manufacturing/process data using statistical tools (e.g., JMP or Minitab) to support trending, investigations, and continuous improvement
• Process validation (PPQ), CPV, and regulatory submissions
• BLA/MAA support and inspection readiness
• cGMP requirements applied to autologous cell therapy manufacturing
• Client-side oversight of CDMO operations
• Prior experience working with TIL or T cells

Bonus Qualifications

• Support of first commercial launch

Remuneration

The anticipated base salary range for this role is $219,000—$267,500 USD. Obsidian is committed to equitable and transparent pay practices. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.

Benefits

We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.

Equal Opportunity Employer

Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.