Director, Manufacturing Science and Technology – MSAT

Obsidian Therapeutics

Director, MSAT leading clinical manufacturing operations at Obsidian Therapeutics. Overseeing technical strategy and execution for novel autologous cell therapies.

Posted 6/8/2026full-timeBedford • Massachusetts • 🇺🇸 United StatesLead💰 $219,000 - $267,500 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

process validationstatistical analysisrisk assessmentroot cause analysisprocess characterizationcontrol strategybatch record authoringvalidation protocolsregulatory submissionsdata analysis

Soft Skills

detail-orienteddata drivenleadershipcollaborationtechnical oversightcommunicationproblem-solvinggovernanceorganizational skillssubject matter expertise

Tools & Technologies

process monitoring databasesmanufacturing campaign review processesCDMO operations oversightBLA readiness materialsPPQ strategy executionanalytical development toolsclinical manufacturing systemsregulatory compliance toolsrisk management toolsstatistical tools

Industry Keywords

MSATautologous cell therapycGMPFDA guidancecell and gene therapycommercial MSATnovel therapyexternal manufacturing modelBLA/MAA supportinspection readiness

About the role

Key responsibilities & impact

Serve as the lead MSAT interface to CDMOs, providing technical oversight of clinical manufacturing
Manage escalations through joint governance forums and collaborate with Process Development
Define and maintain CPPs, CQAs with CDMOs
Partner with Process Development and Analytical Development to define process characterization plans
Define and implement a comprehensive control strategy ahead of PPQ
Own and maintain the integrity of process monitoring databases
Lead manufacturing campaign review processes
Own PPQ strategy and execution
Oversee authoring and review of batch records, validation protocols, and reports
Drive governance of tech transfer plans, protocols, and reports
Structure the MSAT team’s technical materials for BLA readiness
Author and/or review relevant CMC sections of regulatory submissions
Serve as MSAT subject matter expert in support of FDA interactions

Requirements

What you’ll need

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
Knowledge of FDA guidance relevant to cell and gene therapy manufacturing
Strong experience in leading and documenting risk assessments and root cause analysis methods
Analyzing and interpreting manufacturing/process data using statistical tools
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

Benefits

Comp & perks

Comprehensive medical, dental, and vision coverage
Company contributions to health savings and retirement accounts
Ample paid time off
Access to wellness programs
Rich career growth opportunities
Annual incentive bonus as a percentage of actual base salary
Long-term incentives in the form of employee stock options