Principal Scientist

Description

• Lead developability assessments for candidate molecules in collaboration with Research and Pharmaceutical Sciences partners.
• Generate and integrate physicochemical, solid-state, stability, and biopharmaceutical evidence to identify development risks and enable candidate selection.
• Translate characterization findings into clear recommendations for candidate selection, developability risk mitigation, solid-form strategy, and formulation direction.
• Apply solid-state and material techniques, such as XRPD, DSC, TGA, DVS, microscopy, spectroscopy, particle characterization, and related methods; expertise in every technique is not required.
• Characterize impurities including nitrosamines and mutagenic impurities and contribute scientific evidence to multidisciplinary risk assessments.
• Lead or support investigations of unexpected analytical observations, material variability, degradation, stability trends, manufacturing events, and product-performance concerns through orthogonal techniques such as NMR, MS, spectroscopy, chromatography, diffraction, thermal analysis, and microscopy.
• Use fit-for-purpose statistics, data visualization, predictive tools, and in silico / AI-enabled approaches to strengthen experimental design, molecular and material understanding, stability assessment, and biopharmaceutical risk evaluation.
• Collaborate closely with Research, DMPK, Drug Safety, Process Chemistry, Formulation Development, and other partners as appropriate.
• Provide scientific oversight of CROs and external laboratories, including study design, protocol / report review, progress monitoring, data evaluation, and resolution of technical issues.
• Prepare and present study plans, technical reports, risk assessments, scientific recommendations, and development documentation for internal and external partners.
• Contribute characterization content and scientific justification for regulatory documents and responses as appropriate to project phase and role.
• Lead or contribute to initiatives that improve scientific quality, productivity, consistency, knowledge reuse, and technical capabilities across the organization.
• Recognized as a technical expert across Pharm Sci functions
• Serve as a technical resource or mentor for junior staff and leverage expertise in laboratory technology as a functional resource/trainer

Qualifications

Highest qualification: University

• Bachelor’s degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 7+ years relevant industry experience
• Master’s degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 5+ years relevant industry experience
• PhD in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 3+ years relevant industry experience
• Demonstrated ability to independently design studies, integrate data across disciplines, and communicate actionable scientific conclusions.
• Technical knowledge and skills of solid form study, biopharmaceutical assessment and physicochemical profiling of synthetic molecules.
• Understanding of pharmaceutical development and the relationship among candidate properties, material attributes, formulation, process, stability, biopharmaceutics, and analytical strategy.
• Strong scientific judgment, problem-solving, technical writing, presentation, collaboration, and stakeholder-influence skill.
• Experience with in silico tools, predictive modeling, statistics, data science, automation, or AI-enabled scientific workflows.
• Knowledge of analytical techniques with experience in multiple techniques for synthetic molecules such as LC, dissolution, spectroscopy, particle size analysis, XRPD etc.; Able to work in a lab setting and independently interpret results of complex experiments.
• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe.
• Proven external scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts