Pharmica Consulting

CMC Project Manager

Pharmica Consulting - Foster City, CA

CMC Project Manager

Pharmica is looking for a CMC Project Manager for 6-month contract position. The CMC Project Manager will be responsible for providing project management support to teams responsible for management of pharmaceutical products and outsourcing partners. Primary responsibilities will include management of API (Active Pharmaceutical Ingredient) commercial teams supporting chemistry, manufacturing and control and post approval life cycle management program deliverables and CXO teams responsible for oversight of partnerships with contract manufacturing and testing sites. The full scope of projects assigned may include management of development phase programs and biologics teams. Project Manager II will be collaborating with the following groups: Chemical Development and Manufacturing Operations, Global Supply Chain, Analytical Operations, Quality Assurance, Packaging & Labeling, Outsourcing, Regulatory Affairs and Pharmaceutical Manufacturing. The Project Manager II will be responsible for facilitating team meetings and tracking project and department activities including: change management records, action items, timelines, resource plans and other project or department deliverables as required. The Project Manager II will manage multiple products and CXO teams and may be assigned duties associated with PMO office initiatives as required.

Essential Duties and Job Functions:

  • Project management of multiple product and CXO teams
  • Facilitates program communications and documentation with internal teams and external partners as required
  • Collaborates with team to develop and evaluate change proposals and track progress of changes in flight
  • Collaborates with the team to resolve issues and organizes team to execute on the corrective actions
  • Monitors program deliverables and tracks related activities as needed
  • Ensures project work complies with established practices, policies, and processes
  • Supports preparation of materials for product review meetings with PDM leadership
  • Contributes to PMO office initiatives

Knowledge, Experience and Skills:

  • Minimum 6 years of relevant experience and a BA or BS or 4+ years of relevant experience and a MS or MBA. Relevant experience consists of work in cross functional biopharmaceutical /pharmaceutical CMC development, GMP and regulatory affairs
  • Excellent organizational skills, capable of setting priorities and delivering on commitments while, managing high workload
  • Strong communication skills written and verbal including oral presentation skills
  • Experience with API manufacturing, GMP, CMC regulatory submissions, and/or pharmaceutical project management is desirable
  • In-depth knowledge and skill with Microsoft Office (Word, Excel, PowerPoint, Visio, Project, Teams)
  • and SharePoint

 



Posted On: Tuesday, July 7, 2020



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