Senior Scientist, Engineering, Crystallization Lab (Onsite

Job Description

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. The incumbent will develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our different pipeline. This role involves the development of new technologies focused on improving the efficiency of laboratory crystallization development and aims to provide greater process understanding.

The application of state‑of‑the‑art tools, including process analytical technology (PAT) and process modeling, will be integral to the position. Developing subject matter expertise in drying, milling operations, and particle size control, including execution of wet and dry milling experiments, is expected.

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. The incumbent will develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our different pipeline. This role involves the development of new technologies focused on improving the efficiency of laboratory crystallization development and aims to provide greater process understanding.

The application of state‑of‑the‑art tools, including process analytical technology (PAT) and process modeling, will be integral to the position. Developing subject matter expertise in drying, milling operations, and particle size control, including execution of wet and dry milling experiments, is expected. The position involves hands‑on process development and scale‑up work performed at scales spanning benchtop and commercial manufacturing sites. Under scientific direction, the incumbent will perform independent research which involves conceiving, designing, planning, and implementing advanced studies aimed at achieving mechanistic understanding that informs rational process design for the isolation of Active Pharmaceutical Ingredients (APIs) and drug substance intermediates.

The candidate may also have the opportunity to manage crystallization development and/or manufacturing activities at external suppliers. The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP). Highly effective communication and collaboration skills are critical to success because the role has broad impact across the organization.

Specifically, the role includes considerable cross‑functional collaboration as part of integrated drug substance and drug product teams that collectively drive decisions regarding API form and physical attributes. Mentoring chemistry and engineering colleagues to share best practices and guide development toward successful outcomes is a central expectation of the role.

• The position requires either a 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.

• 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 (more than 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…