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CMC Project manager - Chemistry, Manufacturing and Controls (JP8220)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  CMC Project manager - Chemistry, Manufacturing and Controls (JP8220)
Location: Thousand Oaks, CA. (Onsite Essential)
Employment Type:  Contract
Business Unit: CMC Integration
Duration: 1+ years (with likely extensions)
Posting Date: 2/11/21
 
 
3 Key Consulting is hiring a Project Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
  • The Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing and maintaining project schedules for client pipeline projects.
  • This Project Manager will have a significant focus on supporting programs in pre-pivotal phase.
  • Working with the Early Operations Leader and other members of the Product Delivery Team, the PM develops and aligns plans and schedules for PD activities with business priorities.
  • The PM captures associated project risks, develops mitigation plans and communicates project status clearly to impacted stakeholders.
  • The PM assists with driving decision making for the project and ensures that action items are captured and tracked to completion.
  • The PM partners with PD technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities.
  • The PM ensures cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities.
  • The PM assists PD technical leads with tracking the execution of required deliverables and assists with navigating project teams through corporate governance.
  • The PM collect, digest and assemble information to enable relevant business analysis and influence decision-making.
  • The PM will leverage soft skills, technical knowledge, and leadership attributes to influence positive project outcomes.
  • Responsibilities include but are not limited to:
    • Work with technical and/or Product Delivery teams creating project schedules that align with PD prioritization.
    • Support projects that utilize internal and external personnel, contract firms, and partners
    • Assist PD in driving decision making using DAI principles (D- Decision maker, A- Advice Giver, I- Informed)
    • Ensure participation in functional and cross functional management reviews
    • Ensures consistent communication of project performance between the teams and Senior Management
    • Partners with project team members for coordination and development of project presentations to Senior Management
    • Establish and manage collaboration and team SharePoint sites (e.g. My Teams)
    • Manage and prioritize support of multiple project teams at one time
    • Provide meeting management support including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication
    • Track delivery and create repositories for all PD deliverables (Tech Reports)
    • Partner with Business Analysis and Performance to report product metrics
    • Facilitate and incorporate lessons learned, best practices, etc.
    • Support Business Process improvements, including alignment with CMCX
    • Maintain key project milestone dates in PLM database
    • Produce project reporting including appropriate risk analysis
 
 
Why is the Position Open?
Workload is high.
 
 
Top Must-Have Skill Sets:
  • Experience with Microsoft project- Excel, Power Point, PLM databases and SharePoint.
  • Experience with facilitating cross-functional team meetings
  • Previous hands-on experience working in analytical sciences, drug substance/drug product process development or related therapeutic discovery technical role.
  • Bachelor's/Master's degree in engineering or scientific discipline is preferred.
  • Strong interpersonal and communication experience with the ability to effectively interface across all levels of the organization.
 
 
Day to Day Responsibilities:
  • Integrating Process Development (PD) activities by developing and maintaining project -schedules for client pipeline projects.
  • Create and maintain project timelines and working in PLM database.
  • Facilitating cross-functional team meetings within process development.
  • Capturing meeting minutes, decisions and action items for routine project team meetings as well as meetings with PD senior leadership
 
Basic Qualifications:
Doctorate Degree
OR
Master's Degree & 3 years of Project Management or Operations experience
OR
Bachelor's Degree & 5 years of Project Management or Operations experience
OR
Associate's degree & 10 years of Project Management or Operations experience
OR
High school diploma/GED & 12 years of Project Management or Operations experience
 
 
Preferred Qualifications
  • 10+ years of drug development project management experience in the biotech/pharmaceutical industry
  • Bachelor's/Master's degree in engineering or scientific discipline is preferred. Prior experience working in a hands-on role in biologics process development role is a plus.
  • Direct CMC experience
  • Experience in an environment requiring one to foster collaboration and work effectively on cross-functional teams
  • Strong interpersonal and communication experience with the ability to effectively interface across all levels of the organization
  • Experience utilizing critical thinking and problem solving skills to achieve results
  • Ability to Anticipate project constraints and risks; helps to mitigate problems that may impact project progress (scope or timeline)
  • Experience applying standard Project Management tools, and practices
  • Experience with MS Project, Excel, Power Point, PLM databases and SharePoint
 
Employee Value Proposition:
 
 
Red Flags:
  • No non-scientific degrees.
  • No pharma industry experience or otherwise technical laboratory experience.
  • Long gap in employment.
 
 
Interview process:
Manager will phone screen and schedule WebEx/Skype interview.
 
 
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 also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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