CMC Project Planner
Orange County Metro Area, CA
The CMC Project Planner III is responsible for supporting CMC Teams by strategically developing and maintaining Pharmaceutical Science timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports.
PRIMARY JOB RESPONSIBILITIES:
1. Support Pharmaceutical Science teams by developing and maintaining high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
2. Partner with Project Management, CMC and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
3. Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of all CMC milestones. The CMC Specialist will be expected to identify gaps and risks in the CMC plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.
4. Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
5. Responsible for arranging and leading discussions on the CMC plans. Present clear CMC plan reports to stakeholders within the company.
6. Partner with CMC team leaders to tactically drive critical path elements.
7. Operate within the Governance Board model for communication and accountability.
Life science and/or business degree with at least 5-7 years of experience. MS degree and PMP certification desirable.
Strong knowledge of and experience with Pharmaceutical Science development and processes.
Project Management experience required.