For the Principal Research Scientist I position, we are seeking a highly motivated and experienced Process Analytical Technology (PAT) scientist to lead a small team within Analytical R&D. The candidate will establish and execute PAT strategies for synthetic molecule programs, supporting drug substance and drug product development from early development through validation, technology transfer, and manufacturing implementation. The role requires deep technical expertise in PAT method development, chemometrics, process understanding, and fit-for-purpose analytical control strategies.
The successful candidate will perform and direct laboratory and project activities, mentor and develop scientific personnel, and translate complex process and analytical data into clear development decisions. They will conceive, execute, and communicate multidisciplinary strategies that advance project and organizational goals, while serving as a senior PAT subject matter expert across multiple programs and initiatives.
A critical element of the role is strong integration with Analytical R&D project leads and cross-functional partners, particularly Process Engineering, Process Chemistry, Drug Product Development, manufacturing, Quality Assurance, CMC Regulatory, data science, and information technology. The scientist will define practical engagement models that bring PAT expertise into project planning at the appropriate stage and connect PAT outputs to process development, control strategy, validation, and technology-transfer decisions.
Responsibilities:
- Mentor, supervise, and develop a small team of PAT scientists; set priorities, allocate work, provide technical coaching, and ensure effective delivery across multiple development programs while also personally performing hands-on laboratory work.
- Create and maintain an integrated PAT strategy for synthetic molecule drug substance and drug product programs, including clear decision criteria for when and how PAT should be applied across the development lifecycle.
- Establish an effective operating model between PAT experts and Analytical R&D project leads, ensuring early engagement, aligned work packages, clear ownership, and timely translation of PAT results into project decisions.
- Lead PAT feasibility assessments, method and model development, robustness studies, validation, lifecycle management, and technology transfer for in-line, on-line, at-line, and off-line applications.
- Apply chemometrics and multivariate data analysis to develop, challenge, interpret, and maintain quantitative and qualitative models. Ensure models are scientifically sound, appropriately validated, and suitable for their intended use.
- Provide expert leadership in spectroscopic and process analytical techniques such as NIR, Raman, mid-IR/FTIR, UV-visible spectroscopy, particle and material-property measurements, and complementary process sensors.
- Lead or support deployment of on-line liquid chromatography for reaction monitoring, process consistency, impurity or product-quality measurements, and other fit-for-purpose drug substance or drug product applications.
- Integrate PAT measurements with process knowledge, critical process parameters, critical material attributes, and critical quality attributes to support process understanding and analytical control strategy development.
- Partner closely with Process Engineering, Process Chemistry, Drug Product Development, manufacturing, Quality, Regulatory, automation, data science, and IT teams to design interfaces, data flows, system readiness, and sustainable implementation approaches.
- Design material-sparing and risk-based development approaches where appropriate, troubleshoot complex sampling, interface, instrumentation, data-quality, and model-performance issues, and identify practical mitigations.
- Communicate PAT strategy, scientific rationale, risks, and recommendations to technical teams and senior stakeholders through clear written documents, presentations, and decision-focused discussions.
- Generate new scientific proposals, evaluate emerging PAT and digital technologies, and champion innovations that improve development speed, scientific understanding, robustness, and operational efficiency.
- Ensure work complies with applicable safety, quality, data-integrity, regulatory, and AbbVie requirements.