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Steel Components Assembler

Akebia Therapeutics

Steel Components Assembler

Cambridge, MA
Full Time
Paid
  • Responsibilities

    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 6+ years of experience in pharmaceutical development and manufacturing

    OR

    • BS with 10+ 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%).

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com

    Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

     

  • Qualifications
    • 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
  • Industry
    Transportation / Trucking / Railroad