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CMC Operations Senior Project manager - Chemistry, Manufacturing and Controls (JP8332)

Cambridge, MA · Biotech/Pharmaceutical
Job Title:  CMC Operations Senior Project manager - Chemistry, Manufacturing and Controls (JP8332)
Location: Cambridge, MA
Employment Type:  Contract
Business Unit: Business Analysis
Duration: 1+ years (with likely extensions)
Posting Date: 03/05/2021
3 Key Consulting is hiring a CMC Operation Senior Project Manager for a consulting engagement with our client, a leading global biopharmaceutical company.
To apply you must have:
  • Biology/Biochemistry/Biomedical/Chemistry background. No Information Technologies, Function admin, or facility project management.
  • Late stage and life cycle management
  • Commercial process development
  • Process characterization
  • Tech transfer
  • Experience in drug substance, drug product, drug development, cross functional support, combination product, late stage (Commercial Process Development), LCM, CMC operations, process development
  • Strong Microsoft project and office skills

Job Description:
  • 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
Employee Value Proposition:
Exposure to variety of products & many developments, high visibility to senior leadership
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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