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Project Manager - II, Pharmaceutical Development and Manufacturing (PDM)

Cypress HCM Foster City, CA
  • Posted: over a month ago
  • Full-Time
Job Description
 Project Manager – II, Pharmaceutical Development & Manufacturing
 
Description:
  • The Pharmaceutical Development and Manufacturing (PDM) Project Manager II 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 deliverable 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 biologic 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 deliverable 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 deliverable 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
 

Cypress HCM

Address

Foster City, CA
USA

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