Associate Principal Scientist, Engineering Crystallization Laboratory (Onsite)

About this role

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 position involves hands-on process development and scale-up work performed at scales spanning benchtop and commercial manufacturing sites. 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 will 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.

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 8 years of relevant work experience in crystallization process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with at least 3 years of relevant work experience post PhD defense.

Required Experience and Skills ** :   • For BS/MS candidates, at least 8 years of relevant work experience post-graduation - OR – for PhD candidates with at least 3 years of relevant work experience post PhD defense, where relevant work experience would include the following:

• Application 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 (> 5 years, inclusive of time in academia) performing chemical process development, including crystallization process development and/or solid state analysis

• Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale

• Understanding of pharmaceutical drug substance processing • 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

Preferred Experience and Skills: • Background with chemical engineering-related technology development • Familiarity with kilo-scale laboratory equipment • Experience with process modeling (e.g., population balance modeling, distillation modeling) • Knowledge with milling equipment (spiral jet mills, pin mills, co-mills, rotor-stator wet mills) • Working knowledge of drying technologies and unit operations associated with drug substance manufacturing. • Experience with organic chemical synthesis and wet chemistry including running experiments, and generating and analyzing data • Familiarity with drug product processing and experience collaborating across the drug substance/drug product interface • Familiarity with concepts and application of cGMP during pharmaceutical development and production • A high level of innovation, creativity, and self-initiative

#PRD #eligibleforERP

Required Skills: Bioprocessing, Chemical Engineering, Chemical Synthesis, Chemical Technology, Cross-Functional Collaboration, Crystallizations, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Scale-Up, Pharmaceutical Development, Process Improvements, Protein Purifications, Regulatory Submissions Preferred Skills:

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