Process Development Scientist

Key Responsibilities

• Utilize advanced solid-state characterization methods (e.g. ssNMR) to support drug substance and drug product process development for synthetics and biologics programs.
• Drive lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).
• Perform synthetics molecule assessment (developability assessment) and preclinical formulation support.
• Perform biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.
• Provide early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).
• Explore and implement ssNMR techniques to enhance productivity, robustness and efficiency of small molecules and biologics development.
• Take a proactive role in developing and applying innovative ssNMR approaches, demonstrating creativity in solving complex technical problems, for example understanding excipient-drug interactions and quantitative analysis of heterogeneous mixtures.
• Provide solid state characterization support to biopharmaceutics assessment, form screening/selection, and drug substance and drug product process development for synthetics and biologics programs.
• Interface with partners in Process Development and Research and Development.
• Support departmental activities including training staff and presenting scientific results at internal/external meetings.
• Build and maintain strong working relationships with key stakeholders internally and externally.
• Contributes to regulatory filings including IND and NDA as needed and assists in answering questions from regulatory authorities.
• Contributes to Amgen's intellectual property and patent filings.

Basic Qualifications

• Doctorate degree OR Master's degree and 2 years of Scientific experience OR Bachelor's degree and 4 years of Scientific experience

Preferred Qualifications

• Master's degree in one of the following areas: Physics, Materials Science, Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline
• Strong background in ssNMR spectroscopy method development and theory with a record of scientific presentations, such as, peer-reviewed publications
• Experience in ssNMR instrumentation, operation, and maintenance is beneficial
• Specific experience developing ssNMR methods to characterize small and large molecule drug substances and drug products, such as solid form analysis, impurity phase/amorphous content detection and physical stability assessment
• Experience in solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) is desired
• Working knowledge of solid form development such as polymorphism, solvates/hydrates and salt/co-crystal characterization is beneficial
• Good informatics skills and experience with molecular modelling calculations to study molecular interactions and simulate NMR experimental observables is beneficial
• Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements
• Problem solver with a proactive attitude and ability to collaborate and work in a cross-functional and multidisciplinary environment
• Abilities to take initiatives, work independently, and be flexible in responsibilities