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Manager, CMC Project Management

Posted about 2 months ago

  • Expiry Date: 31 July 2022
  • Referral: 211591@accuick.com

Job Description:

  • Collaborate with technical lead and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish project plans including resource loading and risk mitigations for the Technical Operation and Quality Organization.

  • Support the management of internal and external technical requirements with partners, CMOs, and CROs to ensure project success and that contractual obligations and deliverables are met.

  • Management of project plans and timelines for the completion of all activities required to develop, prepare and submit the Chemistry, Manufacturing, and Controls (CMC) sections of Client registration dossiers and amendments for all products.

Required:

  • SUPPLY CHAIN

  • CMC

  • CHEMISTRY

  • EXCEL

  • FDA

  • METRICS

  • MITIGATION

  • PRODUCT DEVELOPMENT

  • PROJECT PLAN

  • PROJECT PLANS

  • TECHNICAL REQUIREMENTS

  • THERAPEUTIC

  • LIFE SCIENCES

  • MANUFACTURING OPERATIONS

  • MICROSOFT EXCEL

  • OPERATIONS

  • REGULATORY AFFAIRS

  • RNA

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.