Terrestrial BioLocation: 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.
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.
