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Engineering / Facilities
Sr. Engineer, Drug Product Development Direct Hire MA
Job ID: 15651 Direct Hire MA
Global biopharmaceutical company here in MA is looking to add a Small Molecule Sr. Engineer to their Drug Product Development team! Company is known for their innovative medicines to treat chronic CNS diseases and has commercial products! Sr. Engineer will help lead the drug product unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. In addition, will 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. Other 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 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.
- MS in Chemical Engineering with 10+ years OR PhD in Chemical Engineering with 3+ years of experience with the development of small molecule or API late-stage products.
- Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities
- Proven ability to apply scientific principles to design, execute and interpret experiments
- Pharmaceutical cGMP manufacturing experience
- Statistical design of experiment experience
- Team player with good interpersonal skills
- Continuous process development and manufacturing
- PAT experience & chemometrics (e.g. NIR, Raman)
- Experience in working with DEA controlled substances
- Quality by Design experience