This position will provide technical leadership for small molecule drug product unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding and robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers. The candidate should have strong communication, a commitment to continuous learning, a strong sense of curiosity and be a good team player. A solid background in chemical engineering is required.
Responsibilities include but are not limited to:
- Collaborate within cross-functional teams, specifically with Formulation and Analytical Development to define and execute development strategies that enable successful launch of Alkermes products
- Implement scale-up strategies for drug product unit operations with a focus on process understanding, identification of critical process parameters and process optimization
- Apply particle engineering and process modeling in development activities. Identify and deploy new technologies as needed.
- Design manufacture processes that deliver drug product of desired attributes
- Support technology transfer of drug product unit operations and production at CMO(s)
- Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11
- Write technical reports and deliver presentations to technical, CMC and broader project groups.
- Author & review CMC sections of regulatory filing documents
- Mentor fellow engineers
Minimum Education & Experience Requirements:
- MS in Chemical Engineering with 10+ years of experience
- PhD in Chemical Engineering with 3+ years of experience