PAT Strategy Lead & Associate Director, MAP Tech

Terrestrial; Woburn (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Principal Scientist / Associate Director to lead the PAT function for the MAP program. You will own the PAT vision, identify and implement in-process analytical technologies, and drive RTRT readiness.

This senior leader will build the PAT sub-function, develop control strategies, collaborate with Manufacturing and Process Development, and prepare regulatory submissions for Phase 3 and commercialization.

Qualifications

• Ph.D. in Analytical Chemistry, Chemical Engineering, or related field with 10+ years of experience (or M.S. with 12+ years).
• Proven track record leading PAT strategy and implementation across development and manufacturing.
• Deep expertise developing PAT methods (spectroscopy, image analysis, or in-line/at-line sensors).
• Advanced chemometrics and multivariate data analysis (PLS, PCA).
• Experience integrating analytical technology into GMP manufacturing processes.
• Strong knowledge of ICH Q8, Q9, Q10, Q14, and FDA PAT guidance.
• Experience developing control strategies and representing PAT in regulatory submissions.
• Demonstrated leadership and cross-functional influence at a senior level.

Responsibilities

• Own and drive the PAT strategy, vision, and roadmap for the VX-201 MAP program across manufacturing.
• Identify and prioritize PAT opportunities including image analysis for needle array geometry, at-line UV/Vis for content monitoring, and NIR for moisture/formulation consistency.
• Lead technology evaluation, vendor selection, and capital procurement for PAT systems.
• Direct the development and validation of PAT methods including chemometric model development (PLS/PCA) and correlation to offline reference methods.
• Establish the PAT control strategy and integrate PAT tools into manufacturing processes with SPC frameworks.
• Partner with Manufacturing, Process Development, and Formulation leadership to align PAT with critical process parameters and quality attributes.
• Define and build the PAT data infrastructure and lead the organization’s transition toward RTRT for Phase 3.
• Author and own PAT sections of regulatory submissions and represent PAT strategy in health authority interactions.
• Establish PAT method qualification, CSV, and data integrity governance under GAMP 5.
• Build, mentor, and grow the PAT sub-function; provide leadership as the team scales toward commercialization.

Skills

PAT

Chemometrics

GMP manufacturing

Regulatory submissions

Education

PhD in Analytical Chemistry or Chemical Engineering

Tools

OpenCV

Python

NIR spectroscopy

Raman spectroscopy

UV/Vis spectroscopy

Job description

Terrestrial Bio, Inc. is seeking a Principal Scientist / Associate Director to lead the PAT function for the MAP program. You will own the PAT vision, identify and implement in-process analytical technologies, and drive RTRT readiness.

This senior leader will build the PAT sub-function, develop control strategies, collaborate with Manufacturing and Process Development, and prepare regulatory submissions for Phase 3 and commercialization.