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CMC Operations Senior Project Manager (JP7171)

Cambridge, MA · Biotech/Pharmaceutical
Job Title: CMC Operations Senior Project Manager (JP7171)
Location: Cambridge, MA
Employment Type: Contract – Onsite (no remote)
Business Unit: CMC Integration
Duration: 12 months  with likely extensions
3Key Consulting is hiring a CMC Operations Senior Project Manager for a contract engagement with our client, a leading international biopharmaceutical company.
Top Must have Skill Sets:
  • 10 years of experience in the Pharmaceutical, Biotechnology or other Healthcare related field
  • Project Management experience
  • CMC experience
  • Experience with Drug substance, drug product, drug development, cross-functional support, combination product, late stage, LCM, process development.

Candidate must have Biology/Biochemistry/Biomedical/Chemistry background. NO IT or facility project management.  

Must recognize:
  • Late stage and life cycle management
  • Commercial process development
  • Process characterization
  • Tech transfer
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
Responsibilities include:
  • 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 company’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
Employee Value Proposition:
Position will work on an innovated drug delivery system that will impact a significant portion of the company portfolio.

Red Flags:
  • NO experience in biotech industry
  • Someone with an IT background, they will be rejected with this type of background

Interview Process:
Initial phone screen followed by Skype Video
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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