Senior Scientist, Engineering, Crystallization Lab (Onsite)

About the role

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual to serve as a crystallization subject matter expert.

Responsibilities

• Develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our different pipeline.
• Develop new technologies focused on improving the efficiency of laboratory crystallization development.
• Aim to provide greater process understanding through the application of state-of-the-art tools, including process analytical technology (PAT) and process modeling.
• Execute wet and dry milling experiments to develop subject matter expertise in drying, milling operations, and particle size control.
• Perform hands-on process development and scale-up work at scales spanning benchtop and commercial manufacturing sites.
• Conceive, design, plan, and implement advanced studies aimed at achieving mechanistic understanding that informs rational process design for the isolation of APIs and drug substance intermediates.
• Manage crystallization development and/or manufacturing activities at external suppliers under scientific direction.
• Exhibit a mindset of safety and quality compliance, adhering to current Good Manufacturing Practices (cGMPs), participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP).
• Communicate and collaborate effectively across multiple projects and with cross-functional teams to drive decisions regarding API form and physical attributes.
• Mentor chemistry and engineering colleagues to share best practices and guide development toward successful outcomes.

Requirements

• Education: BS and/or MS in Chemical/Biochemical Engineering (or comparable) from an accredited college/university plus at least 5 years of relevant work experience in crystallization process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university.
• Experience: Hands-on laboratory experience (> 2 years, inclusive of time in academia) performing chemical process development, including crystallization process development and/or solid state analysis. Experience with crystallization specific Process Analytical Technology (i.e. FTIR, FBRM, Raman, image analysis).
• Skills: Knowledge of crystallization theory and design, such as supersaturation control, crystal phase maps, morphology and particle size manipulation, drying, and the associated unit operations. The ability to balance cross-functional work across multiple projects. Highly effective communication and collaboration skills.

Qualifications

• Knowledge of crystallization theory and design, such as supersaturation control, crystal phase maps, morphology and particle size manipulation, drying, and the associated unit operations.
• Hands-on laboratory experience (> 2 years, inclusive of time in academia) performing chemical process development, including crystallization process development and/or solid state analysis.
• Experience with crystallization specific Process Analytical Technology (i.e. FTIR, FBRM, Raman, image analysis).
• The ability to balance cross-functional work across multiple projects.
• Highly effective communication and collaboration skills.

Skills

• cGMP Regulations, Chemical Engineering, Chemical Synthesis, Chemical Technology, Chromatographic Techniques, Collaborative Communications, Crystallizations, Design of Experiments (DOE), Deviation Investigations, Distillations, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Process Models, Process Scale Up, Small Molecule Synthesis.
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