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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
Sr. Manager, Manufacturing Technologies Direct Hire MA
Job ID: 15650 Direct Hire MA
Do you love Gene Therapy, Innovation & New Technologies?! Then this is the role for you! Newly created role with mid-size Gene Therapy Company here in Cambridge, MA looking for Sr. Manager, New Technologies focused on the future roll out of Autologous Cell Production! This is a highly visible role that is a mix of technical knowledge, project management and systems integration. Sr. Manager will support the implementation of new manufacturing and analytical technologies and work with CMC, Process Development, Manufacturing, IT, Quality & R&D teams to bring autologous manufacturing in house! Other responsibilities include:
- Drive strategy evolution and alignment towards bringing new technologies aimed at enhancing ability to scale manufacturing and reduce COGS of advanced cellular therapeutics.
- Lead cross-functional team in developing and implementing holistic plans for the identification, evaluation, development, and integration of potential new technologies, processes, and operational models.
- Provide on-going project and alliance management support.
- Collaborate with CMC project leadership to integrate manufacturing technology project plans with individual program-specific CMC needs and timelines.
- Proactively identify risks, gaps, and resource bottlenecks; work with teams to develop and implement mitigation plans.
- Lead development of proposals for leadership meetings to facilitate decision-making.
- Contribute to objective setting and long-range budget planning.
- Facilitate cross-functional team interactions with key functional stakeholders by building strong working relationships across the organization.
- Advanced degree in scientific/engineering discipline and 5+ years of relevant industry experience.
- Ability to influence peers and senior leadership.
- Working knowledge of technologies relevant to autologous cell production to enable integration of strategies around manufacturing data systems, cell processing, and analytical testing. (Expertise specifically in data systems a definite plus.)
- Experience working in high-volume, matrix environments.
- Up to 20% travel may be required.