Job Title: CMC Operations Manager
Job Number: 24840
The CMC Operations Manager will be integral in the planning and execution of CMC product development projects that support clinical supply needs while adhering to budget, scope and schedule requirements. This position helps ensure consistent practices throughout all phases of the project life cycle.
- As an integral part of the CMC project team, develop and maintain timelines, and appropriately document, track, and communicate decisions and actions
- Coordinate with clinical team to ensure adequate and timely supply of clinical trial materials
- Develop and monitor high quality, integrated cross-functional plans for projects
- Apply best practices in the development, initiation, planning, execution, control and closing of projects
- Interact with R&D, clinical, and regulatory departments as well as Contract Manufacturing Organizations (CMOs)
- Excellent written and verbal communication skills
- Ability to work independently and with a team
- Skilled in MS Project or other project management software
- B.S./M.S. Degree.
- 5-10 years minimum experience in project management and clinical supply operations
- Biotech/Pharma industry experience is a plus