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Nivagen Pharmaceuticals

CMC Project Manager Pharmaceuticals

United States-California-Sacramento


Company Information

Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market. Our vision is to deliver high quality products at affordable prices by leveraging global partnerships with the best FDA approved manufacturing facilities across the world.

Our sales and marketing personnel are among the best in the world. The US generic prescription market is currently at approximately $60 billion, and over $120 billion's worth of products will be coming off of patent protection in next 10 years. Nivagen believes that, with its strategic partnership model of global alliances with highly efficient pharmaceutical companies across the globe, we can provide cost savings to the consumer while creating value for all members of the supply chain.

Nivagen is focused in three areas of product development: development/co-development, acquisition/in-licensing, and providing sales and marketing services. We are actively looking to partner with CRO and CRAM to co-develop products. We are also acquiring existing products. If you are small FDA qualified manufacturer and want to launch your company or product in the US, Nivagen can provide complete turnkey solutions and cost effective delivery on an accelerated timeline.

Job Description

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.

Position Requirements

  • 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

Contact Information

Nivagen Pharmaceuticals
Olivia Girado
Executive Assistant
Posting Date: 23-Aug-2017Science and Research Permanent, Full-Time Open 1 ASAP
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