Senior Scientist Chemical Engineering in Cambridge, MA

$100K - $150K(Ladders Estimates)

Akebia Therapeutics, Inc   •  

Cambridge, MA 02138

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 43 days ago

Job Description

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.

Required Skills

  • 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

Required Experience

Basic Qualifications:

  • MS with 8+ years of experience in pharmaceutical development and manufacturing

OR

  • BS with 12+ years of experience in pharmaceutical development and manufacturing.

Preferred Qualifications:

  • 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%).


Valid Through: 2019-10-28