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

About the 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.

Responsibilities

• 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.

Requirements

• 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.

Benefits

At Terrestrial, we offer a competitive benefits package that includes:

• Health insurance
• Retirement savings plan
• Flexible work arrangements
• Professional development opportunities

Pay

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.

Schedule

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.