Position Summary

The Associate Manager, CMC Project Management will assist in the maintenance of operational systems that enable GXP activities in the development and commercial environment, including project plans with regards to resources, budgets, plans and timelines. This individual will be expected to collaborate with Regulatory, Quality Assurance, Clinical Operations and Clinical Program Management departments across Odonate to ensure operational activities in line with corporate goals.

Essential Duties and Responsibilities

  • Assist in monitoring project plans with regards to resources, budgets and timelines across projects within Technical Operations department
  • Communicate with Technical Operations team and consultants to address issues and to ensure that functional plans are harmonized, risks identified and critical decisions are made in a timely manner
  • Assist with tracking and communicate project progress to direct supervisor
  • Day-to-day participation in internal Technical Operations meetings and external vendor meetings, including keeping records of meeting minutes, tracking action items and following up with Technical Operations team, consultants and external vendors to ensure agreed upon project milestones are met
  • Assist with tracking the requisition, submission, review and approval process of Technical Operations contracts with the Legal and Accounting
  • Assist with documentation storage and organization for Technical Operations team, including use of company shared drives and web-based document sharing sites

Qualifications

  • Bachelor’s Degree in Chemistry or related science required
  • Minimum 3 years of experience in a GMP bio-pharmaceutical industry required
  • General understanding of the pharmaceutical development requirements for small molecule based drugs required
  • Must have working knowledge of CGMPs (CFR/ICH/EU) and applicable international regulations and guidelines
  • Previous experience with analytical and process development, manufacturing and supply chain
  • Excellent organizational skills with the ability to manage staff, projects, resources, timelines and budgets
  • Strong project management skills with an emphasis on organization, creative thinking and problem solving
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
  • Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
  • Advanced proficiency in Microsoft Office (Word, Power Point, Excel and Project)

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