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

Location:

Allston, MA and Woburn, MA

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

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…