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location: Irvine, California
job type: Contract
salary: $70.67 - 83.14 per hour
work hours: 9 to 5
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. This person will work in a team orientated environment and is empowered to drive Pharmaceutical Science activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements.
- Support Pharmaceutical Science teams by developing and maintaining high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
- Partner with Project Management, CMC and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
- 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.
- Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
- Responsible for arranging and leading discussions on the CMC plans. Present clear CMC plan reports to stakeholders within the company.
- Partner with CMC team leaders to tactically drive critical path elements.
- Operate within the Governance Board model for communication and accountability.
- Provide continuous improvement on CMC plans and standard Planisware templates.
- Assist in developing the department portfolio based schedules and resource planning methodologies.
- Identify state of the art planning tools to minimize deviations.
- 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.
- Excellent written, communication and organizational skills.
- Strong MS Project and/or Planisware experience required.
- Ability to multi-task and perform under demanding and aggressive timelines while remaining focused on the CMC project goals.
- Proven ability to interact with different functional groups.
skills: Project Management, CMC, MS-Project, Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.