Process Development Scientist (Solid State Characterization)

About the role

Amgen's Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Cambridge, MA, is seeking a Process Development Scientist. SET acts as a key drug product technology interface with partners in Process Development and Research & Discovery. The scientist will provide solid state characterization, with a strong focus on solid state NMR (ssNMR) spectroscopy, for drug substance and drug product process development for synthetics and biologics programs.

Key responsibilities

• Use advanced solid-state characterization methods, especially 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 using 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 supporting clinical manufacturing (GMP).
• Develop and apply ssNMR techniques to characterize the structures and interactions of small and large drug molecules, including excipient-drug interactions and quantitative analysis of heterogeneous mixtures.
• Interface with partners in Process Development and R&D, and support training staff and presenting scientific results at internal and external meetings.
• Build relationships with key stakeholders and contribute to regulatory filings (IND, NDA) and intellectual property and patent filings.

Required profile

• Doctorate degree, or Master's degree with 2 years of scientific experience, or Bachelor's degree with 4 years of scientific experience.
• Preferred: Master's degree in Physics, Materials Science, Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry or a related field.
• Preferred: record of scientific presentations such as peer-reviewed publications, and experience developing ssNMR methods for small and large molecule drug substances and products.
• Preferred: good informatics skills, experience with molecular modelling calculations, and excellent written, verbal and presentation skills.

Required skills

• Preferred: strong background in ssNMR spectroscopy method development and theory, and experience with ssNMR instrumentation, operation and maintenance.
• Preferred: experience with solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization).
• Preferred: working knowledge of solid form development such as polymorphism, solvates/hydrates and salt/co-crystal characterization.

What we offer

• A competitive benefits package including a retirement and savings plan, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program or, for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where possible.