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Bilingual Spanish Fiscal Consultant

Akebia Therapeutics

Bilingual Spanish Fiscal Consultant

Cambridge, MA
Full Time
Paid
  • Responsibilities

    This is an outstanding leadership opportunity to join a fast-paced company with a robust development program. Akebia is seeking a motivated and talented Analytical Development professional to join the CMC Operations department. The successful candidate will lead drug substance and product analytical development from early stages to commercialization. This individual will report to the Director of Analytical Development, supervise Analytical Development scientists, and work with cross-functional teams and external partners to lead analytical chemistry projects. The position will be responsible for developing analytical controls strategy and overseeing activities at contract development and manufacturing organizations in North America, Europe and Asia.

    Required Skills

    • Provide analytical oversight of external vendors for preclinical and Phase I - commercial CMC activities for small molecule drug substance (DS) and drug product (DP).
    • Provide oversight and direction for phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control samples, DS, and DP at CMOs.
    • Supervise analytical development professionals responsible for DS and DP analytical workflow.
    • Assist with the development and management of the Analytical Development function budget.
    • Create or modify Standard Operating Procedures associated with the Analytical Development portfolio.
    • Participate in the development and revision of product specifications, provide scientific input and critique analytical results.
    • Review the quality control testing of supplies manufactured at contract development and manufacturing organizations (CDMOs).
    • Manage stability studies for DS and DP.
    • Participate in the preparation of CMC sections of regulatory submissions along with other functional groups.
    • Ensure compliance with analytical requirements for CMC regulatory submissions.
    • Familiarity with a broad range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis (e.g., KF, dissolution, etc.), spectroscopic techniques, particle size, and heavy metal analysis.
    • Understand the DS and DP development process and their impact on analytical method development, validation strategies and specifications.
    • Participate in analytical investigations for deviations/OOS/OOT and ensure proper corrective actions are taken.
    • TRAVEL REQUIREMENTS: willingness to travel domestically and internationally to contract development and manufacturing organizations sites.

     

    Required Experience

    BASIC QUALIFICATIONS:

    • Master’s degree in Chemistry, Pharmaceutical Chemistry or related discipline with 10+ years’ experience

    OR

    • PhD in Chemistry, Pharmaceutical Chemistry or related discipline with 7+ years’ experience

    • Experience in analytical development, technology transfer and oversight of activities at contract development and manufacturing organizations.

    • TRAVEL REQUIREMENTS: willingness to travel domestically and internationally to contract development and manufacturing organizations sites.

    • No relocation available for this role

     

     

    PREFERRED QUALIFICATIONS:

     

    • Strong analytical, communication, presentation, and writing skills.
    • Regulatory and supervisory experience.
    • Ability to manage priorities and maintain timelines in a fast-paced environment.
    • Ability to work cross-functionally.
    • Regulatory and supervisory experience.
    • Excellent problem-solving skills.

     

    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
    • Provide analytical oversight of external vendors for preclinical and Phase I - commercial CMC activities for small molecule drug substance (DS) and drug product (DP).
    • Provide oversight and direction for phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control samples, DS, and DP at CMOs.
    • Supervise analytical development professionals responsible for DS and DP analytical workflow.
    • Assist with the development and management of the Analytical Development function budget.
    • Create or modify Standard Operating Procedures associated with the Analytical Development portfolio.
    • Participate in the development and revision of product specifications, provide scientific input and critique analytical results.
    • Review the quality control testing of supplies manufactured at contract development and manufacturing organizations (CDMOs).
    • Manage stability studies for DS and DP.
    • Participate in the preparation of CMC sections of regulatory submissions along with other functional groups.
    • Ensure compliance with analytical requirements for CMC regulatory submissions.
    • Familiarity with a broad range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis (e.g., KF, dissolution, etc.), spectroscopic techniques, particle size, and heavy metal analysis.
    • Understand the DS and DP development process and their impact on analytical method development, validation strategies and specifications.
    • Participate in analytical investigations for deviations/OOS/OOT and ensure proper corrective actions are taken.
    • TRAVEL REQUIREMENTS: willingness to travel domestically and internationally to contract development and manufacturing organizations sites.

     

  • Industry
    Transportation / Trucking / Railroad