Akebia Therapeutics is seeking a Senior Scientist to join its Technical Services team in support of the API development/manufacturing. Reporting to Senior Director of Technical Services, the ideal candidate will be well-versed in chemical engineering fundamentals, chemical process development, pharmaceutical regulatory requirements and scale-up with the ability to apply their skills to drive understanding and implementation of processes.
The candidate will work as part of a multidisciplinary team to optimize and troubleshoot commercial manufacturing processes. A strong background in drug substance scale-up, process implementation and validation in a GMP commercial manufacturing facility is desired.
- Hands on oversight of the API GMP manufacturing process at CDMOs with a focus on process improvements and expedient resolution of critical manufacturing issues
- Identify and control process risks, through the use of quality tools and process instructions & design.
- Evaluate equipment variability across manufacturing sites to bring about operational and manufacturing consistency
- Gather data from a variety of sources and analyze to achieve a root cause resolution of technical issues
- Communicate findings and implement preventative measures to ensure process improvements are maintained
- MS with 8+ years of experience in pharmaceutical development and manufacturing
- BS with 12+ years of experience in pharmaceutical development and manufacturing.
- Degree in Chemical Engineering
- Excellent knowledge of API tech transfer, scale-up and clinical/commercial manufacturing. Experience with multiple products across different product lines, reflecting a breadth of understanding of plant scale manufacturing.
- Proven experience in solving issues from a technical and process perspective, using quality tools
- GMP experience
- Ability to transfer and validate processes at CDMOs and third parties for development and cGMP manufacturing.
- Strong knowledge of root cause analysis, statistical analysis tools, DoE, and modeling for mixing/reactor, heat transfer, and filtration/drying for predictive scale up and transition of safe, sustainable, and robust chemical processes, tailored for implementation with the equipment and capabilities of the facility.
- Experience in utilization of kinetic data to support process modeling.
- Fundamental knowledge of surface and material interface.
- Computer skills – excel, word, power point, JMP.
- Ability to effectively communicate and collaborate with internal and external stakeholders is essential.
- Must be willing to travel to CDMO locations for on-site support (up to 20%).