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    CMC Technical Officer, Center for Vaccine Innovation and Access - new delhi, India - PATH

    PATH
    PATH new delhi, India

    1 week ago

    Default job background
    Full time
    Description

    PATH is currently recruiting

    for a CMC Technical Officer to provide tactical and operational support for the Polio vaccine project.

    Responsibilities

    Process Development, Scale up, Technology Transfer

  • Coordinate the technology transfer of viral vaccine manufacturing processes between manufacturers covering process and analytical transfer at full production scale.
  • Work with polio vaccine manufacturing partners in Low- and Middle-Income Countries (LMICs) to conduct manufacturing and analytical data analysis, including translation of results into decisions related to CMC development and manufacturing procedures. Review manufacturing and CMC development data to ensure accuracy, validity, and sufficiency for optimization and scale-up of the manufacturing and analytical processes under Good Manufacturing Practices (GMP).
  • Support regulatory submissions such as eCTD Modules 2.3 and 3, by authoring or coordinating the authorship of CMC content.
  • Participate in process troubleshooting and identify root causes of deviations.
  • Periodically track and trend stability data from manufacturing partners.

    • Clinical Supply

  • Accountable for clinical supply readiness and shipment from manufacturing partners to clinical sites.
  • Assess clinical supply availability, formulate strategy and provide oversight for expiry dating, material availability, and supply demand.

    • Strategy

  • Participate in the establishment of short- and long-term CMC development and manufacturing strategies, including facilities allocation and release testing.
  • Prepare and review reports for partners and donors including project status, risk identification, and potential mitigation strategies.

    • Required skills and experience

  • PhD and a minimum of 5-7 years late-stage process development or manufacturing experience in pharma highly desired; or a Master's degree and a minimum of 8-10 years late-stage process development or manufacturing experience required.
  • Experience performing CMC manufacturing and compliance activities including gap analysis and risk assessments. Experience with process validation required.
  • Demonstrated current working experience with cGMP.
  • Proven experience with assay development, qualification, and validation. Must be able to review and edit assay validation protocols and reports. Experience with assays for viral vaccines, such as viral culture potency assays, PCR, etc. Next Generation Sequency familiarity preferred.
  • Demonstrated experience with manufacturing process characterization and evaluation, such as design, execution, and analysis of DoEs.
  • Strong communication skills for project reports and funder engagements, including technical reports and slide presentations.
  • Proven experience authoring and reviewing CMC content of regulatory submission technical documentation.
  • Knowledge and exposure of technology transfer to ensure transfers are successful, such as authorship of analytical comparability protocols and tech transfer reports.
  • Experience authoring subcontractor scopes of work with external manufacturers, including budgeting. Experience contracting with CDMOs highly desired.
  • Understanding implications of release criteria on overall program development highly desired.
  • Proficiency in Microsoft Office Suite (Teams, Outlook, Word, PowerPoint).
  • Must have legal authorization to work in the US, Belgium, Switzerland, UK, or India. Fully remote candidates in these locations will be considered.
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