CMC Project Manager - Pharmaceutical
Full-time CMC project manager position based in Sacramento, CA. Reports directly to the VP of Research and Development. Position responsibilities include, but are not limited to:
- Effective participation, management and leadership of multiple ANDA and NDA projects of varying complexity and duration.
- Establishment of project timelines and coordination with validated network of CROs and CMOs in order to achieve all key project deliverables and milestones.
- Directly manage completion of multiple dossier components to meet project timelines.
- Positive facilitation and collaboration with cross-functional groups, both internally and externally, in development of appropriate milestones and resource planning.
- Ensure the project achieves all targeted objectives including budget, schedule and resources.
- Organize and facilitate regular project review meetings to ensure projects are on track, review progress, and address project management and strategic issues, including:
- Evaluation of risk management
- Assessment, communication, and mitigation of risks associated with the fulfillment of project commitments and expectations
- Periodic reporting to management on status, schedule progress and performance of the project.
- Responsible for preparation and maintenance of project lists and management dashboards.
- Bachelor’s degree in life sciences or related scientific discipline.
- Minimum 2 year of experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
- Strong technical writing skills and attention to details.
- Experience with preparation of CMC submissions (ANDA, NDA)
- A background in business is desirable but not a required.
Job Type: Full-time