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Materials Engineer

Akebia Therapeutics

Materials Engineer

Cambridge, MA
Paid
  • Responsibilities

    As part of the Akebia CMC Operations Management team, the External Manufacturing Manager will be responsible for managing all aspects of key initiatives and projects in the Akebia external commercial manufacturing network of functions, which includes Operations Management, Technical Operations, Supply Chain, Quality, Process Development, Finance and Legal. The External Manufacturing Manager will lead cross-functional teams to support the development of consistent, robust processes and systems to ensure quality and supply reliability with Akebia external commercial manufacturing network.

    Required Skills

    • CMO-facing partner for Akebia within the CMC Operations group.
    • Responsible for the day-to-day oversight of drug substance commercial manufacturing at the contract manufacturing sites.
    • Will give direction, oversight, and guidance to the external commercial manufacturing sites to ensure timely and quality Akebia commercial supply as well as operations goals met.
    • Act as the primary point of contact with the CMO.
    • Responsible for leading and coordinating the collective voice of Akebia cross-functional teams including Quality, Regulatory, Technical Operations, Finance, Strategic Sourcing, Legal, as well as Business Development in order to support all activities facing the CMO.
    • End-to-end responsibility for the manufacturing activities assigned to CMOs.
    • Utilize project management processes and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards to ensure the commercial supplies.
    • Resource planning, generating metrics/ KPIs and preparation of presentation materials for management reviews and governance meetings.

    TRAVEL REQUIREMENTS:

    • Travel domestically and internationally, up to 25%.

    Required Experience

    Basic Qualifications:

    Bachelor’s Degree in Chemistry, Chemical Engineering, or Pharmaceutical Sciences

    and 8+years of multi-disciplinary experience in biotech/pharmaceutical industry

    OR

    MS Degree in Chemistry/Chemical Engineering/Pharmaceutical Sciences

    5+ years of multi-disciplinary experience in biotech/pharmaceutical industry

     

    Preferred Qualifications:

    • First-hand knowledge chemical manufacturing as either a CMO manufacturer for external customers, in-house captive supplier within an organization, or previous experience managing an externally sourced GMP supply chain for chemical production/API.
    • Experience working with external partners and vendors in API contract manufacturing.
    • Demonstrated ability to lead productively in a highly cross-functional, interdisciplinary environment.
    • Ability to plan and facilitate effective, efficient meetings; excellent communication skills.
    • Strong business knowledge of biotech/pharma manufacturing operations, product and process development, finance, and supply chain operations.
    • Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, practices, and statutes.
    • Knowledgeable in relationship management, chemical manufacturing, and GMPs.
    • Strong interpersonal skills to develop effective working relationships with internal stakeholders, CROs/CMOs, and cross-functional, cross-cultural project teams.
    • Proven ability to develop and manage business relationships.

     

    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
    • CMO-facing partner for Akebia within the CMC Operations group.
    • Responsible for the day-to-day oversight of drug substance commercial manufacturing at the contract manufacturing sites.
    • Will give direction, oversight, and guidance to the external commercial manufacturing sites to ensure timely and quality Akebia commercial supply as well as operations goals met.
    • Act as the primary point of contact with the CMO.
    • Responsible for leading and coordinating the collective voice of Akebia cross-functional teams including Quality, Regulatory, Technical Operations, Finance, Strategic Sourcing, Legal, as well as Business Development in order to support all activities facing the CMO.
    • End-to-end responsibility for the manufacturing activities assigned to CMOs.
    • Utilize project management processes and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards to ensure the commercial supplies.
    • Resource planning, generating metrics/ KPIs and preparation of presentation materials for management reviews and governance meetings.

    TRAVEL REQUIREMENTS:

    • Travel domestically and internationally, up to 25%.
  • Industry
    Transportation / Trucking / Railroad