Principal Research Scientist I - Analytical R&D
Core
Lead a small team to establish and execute Process Analytical Technology (PAT) strategies for synthetic molecule drug substance and drug product development, from early stages through validation and manufacturing.
Role type
Senior IC Principal Research Scientist (Analytical R&D)
Builds
Integrated PAT strategies, quantitative/qualitative chemometric models, and analytical control strategies for drug development programs.
Domain
Pharmaceutical industry, Process Analytical Technology (PAT), Chemometrics
Deliverable
production ML models | product features
Required skills
PAT strategy development, chemometrics, multivariate data analysis, spectroscopic techniques (NIR, Raman, FTIR, UV-visible), on-line liquid chromatography, team leadership, cross-functional collaboration, regulatory compliance
Preferred skills
Biologics/PAT application, PAT data-management systems, advanced process control, real-time release testing concepts
Technologies
Unscrambler, PLS_Toolbox, SIMCA, MATLAB, Python, R, UHPLC
Responsibilities
Mentor and supervise a small team of PAT scientists; develop and maintain integrated PAT strategies; lead feasibility assessments, method/model development, validation, and technology transfer; apply chemometrics for model development and lifecycle management; integrate PAT measurements with process knowledge and critical quality attributes; partner with cross-functional teams (Process Engineering, Chemistry, Manufacturing, Quality, Regulatory, IT); troubleshoot complex instrumentation and data-quality issues; communicate scientific rationale and recommendations to stakeholders.
Seniority
Principal, hands-on IC with team leadership
