Associate Principal Scientist, Engineering Crystallization Laboratory (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. The incumbent will develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our different pipeline.

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 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 APIs and drug substance intermediates.
• Manage crystallization development and/or manufacturing activities at external suppliers.
• Exhibit a mindset of safety and quality compliance, which includes following current Good Manufacturing Practices (cGMPs), participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP).
• Communicate and collaborate effectively 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: Minimum Requirement: 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.
• Experience and Skills: Application of crystallization theory and design, 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.

Qualifications

• Education: Minimum Requirement: 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.
• Experience and Skills: Application of crystallization theory and design, 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.

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.

Benefits

The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.