Principal Scientist​/Associate Director, Process Analytical Technology; PAT) Lead

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Terrestrial's proprietary Tacterra microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit

Allston, MA and Woburn, MA

We are seeking a Principal Scientist / Associate Director to lead the Process Analytical Technology (PAT) function for the microneedle array patch (MAP) program. This individual will own the PAT vision and strategy end-to-end identifying, developing, and integrating in-process analytical technologies including image analysis/machine vision, at-line spectroscopy (UV/Vis, NIR), and real-time process monitoring across the manufacturing lines. As a senior technical leader, this person will build and grow the PAT sub-function, shape the analytical control strategy, and drive the organization toward real-time release testing (RTRT) and Phase 3 IND readiness.

This role combines deep technical expertise with strategic program leadership and cross-functional influence.

• Own and drive the overall 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 (e.g. spectroscopy and machine vision).
• Direct the development and validation of PAT methods including chemo metric model development (PLS/PCA) and correlation to offline reference methods.
• Establish the PAT control strategy and integrate PAT tools into manufacturing processes with robust Statistical Process Control (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 Real-Time Release Testing (RTRT) for Phase 3 and commercialization.
• Author and own PAT sections of regulatory submissions and represent PAT strategy in health authority interactions and inspections.
• Establish PAT method qualification, computer system validation (CSV), and data integrity governance under GAMP 5.
• Build, mentor, and grow the PAT sub-function; provide technical and organizational leadership as the team scales toward commercialization.

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