Principal Scientist, Chemical Engineering R&D

Principal Scientist, Chemical Engineering R&D

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual for the Crystallization Lab. Through direct, lab-based contributions and scientific supervision of junior crystallization subject matter experts, the principal scientist collaborates with cross-functional teams to ensure small molecule Active Pharmaceutical Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the field of crystallization, this role offers the unique opportunity to influence API phase selection and isolation procedures employed across the portfolio. The principal scientist 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, and Good Documentation Practices (GDPs).

In addition to supporting pipeline activities, the principal scientist is expected to support innovative processes and technologies aimed at improving the performance and efficiency of crystallizations to realize desired API physical properties across scales. Serving as an example for scientific excellence, the principal scientist advocates technical growth opportunities through collaboration with internal resources and academic or industrial partners. In partnership with the Director of Chemical Engineering R&D and/or the Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of junior engineers.

A high level of innovation, creativity, and self-initiative along with the ability to balance and prioritize activities across multiple projects are expected. Successful candidates will be required to communicate regularly, clearly, and with confidence as they discuss technical problems, support pilot plant operations, and interface with cross-functional colleagues/customers in drug substance, drug product, and material science. Mentoring chemistry and engineering colleagues to share best practices and guide their development toward efficiently achieved successful outcomes is a central expectation of the role.

Position Qualifications

Education Minimum Requirement: The position requires either a BS and/or MS in Chemical/Biochemical Engineering (or comparable) from an accredited college/university plus at least 12 years of relevant work experience in process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with at least 7 years of relevant work experience post PhD defense.

Required Experience and Skills:

• Experience performing lab-based crystallization development and/or solid-state analysis.
• Experience with early-phase crystallization development, including solvent solubility, salt and form screens and phase map generation to develop crystallizations for first GMP deliveries.
• Experience with developing crystallizations to control and optimize the purity profile of API and intermediates by applying mechanistic understanding of impurity rejection.
• Documented successes of scale-up and technology transfer for small molecule crystallizations, moving from laboratory to pilot plant or production scale through empirical approaches or process modeling.
• Experience with crystallization Process Analytical Tools (e.g., FTIR, FBRM, Raman, image analysis), common off-line analytical techniques (e.g., HPLC, GC, SEM, NMR), and data-rich experimentation concepts, practices, and equipment.
• Proven track record for scientific excellence that includes scientific publications and external conference presentations, as well as commercialization of crystallization processes.
• Technical leadership experience, including examples of mentoring technical staff in the laboratory.
• Highly effective communication and collaboration skills.
• Good organizational, interpersonal, writing, and time management skills.

Preferred Experience and Skills:

• Experience with concepts and application of cGMP and GDP during pharmaceutical development and production, across multiple scales on multiple projects.
• Experience with the scale-up of filtration and drying operations with consideration for the impact on API attribute control and phase and chemical stability.
• Involvement in academic and/or industrial collaborations focused on the advancement of crystallization methods and technology.
• Experience with crystallization procedures and practices beyond traditional small molecules, such as peptides, macrocyclic molecules, and novel modalities.

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