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

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

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 www.terrestrialbio.com.

Location

Allston, MA and Woburn, MA

Why this role

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.

What You'll Do

• 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 chemometric 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.

Who You Are

• 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 interactions.
• Demonstrated leadership, mentoring, and cross-functional influence at a senior level.

Preferred Qualifications

• Experience with NIR/Raman spectroscopy and at-line UV/Vis.
• Prior experience leading or implementing Real-Time Release Testing (RTRT).
• Experience with image analysis libraries and custom vision development (e.g. OpenCV, Python)
• Experience with drug-device combination products or novel delivery platforms.
• Experience building and scaling a PAT or process analytics function.
• Familiarity with computer system validation (CSV) under GAMP 5.

Key Competencies

• Strategic leader able to set vision and connect analytical technology to process, quality, and business outcomes.
• Strong cross-functional influence and executive communication.
• Proven ability to build and grow high-performing technical teams.
• Comfort operating in a build-phase environment with evolving priorities.

Compensation: The anticipated base salary range for this position is $140,000 - $180,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Onsite expectations: The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location: Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026.

At Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.