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CMC Operations Senior Project Manager

Cambridge, MA
Day to Day Responsibilities:
  • Responsible for developing and maintaining project schedules for Amgen life-cycle management
  • projects and providing general project management support to product delivery teams.

Summary
  • Must be able to work onsite, M-F, no remote work
  • Must have Biology/Biochemistry/Biomedical/Chemistry background.
  • NO IT or facility project management.
  • Please do not submit unless they have that specific background.**

Must recognize:
  • late stage and life cycle management
  • Commercial process development
  • Process characterization
  • Tech transfer
  • Key words on resumes: drug substance, drug product, drug development, cross functional support, combination product, late stage, LCM, CMC operations, process development
  • Preferred qualifications
  • At least 2 years of experience as a project manager
  • 10 years of experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable
  • Microsoft project and office skills
  • Soft skills to work of cross functional teams
  • Critical thinking and problem-solving skills
  • The Sr Project Manager will be responsible for integrating and understanding Process Development activities by developing and maintaining product project timeline across the commercialization lifecycle within Amgen’s commercial portfolio.
  • The Sr. PM will lead cross-functional teams within Process Development across all modalities and across all commercialization stages as needed.
  • They will partner with technical leads to identify key deliverables, ensure cross functional alignment, and execute plans.
  • They are expected to proactively manage plans to meet deliverables with their teams.
  • Partnering with key Product Delivery Team stakeholders, the Sr. PM will need to understand the Clinical Development Plan and strategy to enable alignment with clinical and commercial targets
  • The Sr. PM will draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions
  • Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings
  • Assist PD in driving decision making and communication
  • Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables
  • Project reporting including appropriate risk analysis
  • Partner with Business Analytics and functional partners as needed to provide data
  • Facilitate and incorporate lessons learned, standard methodologies, etc.
  • Support Business Process improvements, including alignment with the Commercialization Office
"This posting is for Contingent Worker, not an FTE"

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