Process Engineering supports the development of scalable processes to manufacture small molecule APIs, ADCs, toxins, CAIs, and drug products; ensuring safe, scalable operation through preclinical/clinical stages. In early development, ensure safe runnability and address scale-up issues; in later stages, optimize processes, lead manufacturing campaigns, transfer processes to manufacturing sites, develop control strategy, and support regulatory filings.
Role Overview
- Key role in the Center of Excellence in Crystalline Drug Substance and Drug Product (CrySP), developing robust crystallization-based drug substance and drug product processes.
- Develop isolation and purification strategies for small and large molecules.
- Lead identification and development of novel approaches/technologies to enhance process development efficiency and commercialization; collaborate cross-functionally to meet project needs.
Key Responsibilities
- Develop robust scale-up and manufacturing processes for small and/or large molecule assets.
- Perform laboratory experiments and process modeling for understanding and optimization.
- Solve separation/isolation challenges using thermodynamics, crystallization fundamentals, transport phenomena, and mathematical modeling.
- Author and/or review technical documents summarizing process development.
- Collaborate with multidisciplinary teams; communicate findings and recommendations.
- Author publications and present at scientific conferences.
Qualifications
- BS/MS/PhD in Chemical Engineering or related field; 10+ (BS), 8+ (MS), or 0+ (PhD) years relevant industrial experience.
- Strong chemical engineering background; ability to master new experimental techniques.
- Effective oral and written communication; strong team player.
Benefits (if applicable)
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Eligible for long-term incentive programs.