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CMC Project Manager - Biopharma (JP7766)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: CMC Project Manager - Biopharma (JP7766)
Location: Thousand Oaks, CA    
Employment Type: Contract
Business Unit: CMC Integration LCM PM 
Duration: 3 years
Job posting date: 10/5/2020
Note: Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a CMC (Chemistry, Manufacturing and Control) Project Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary for Project Manager within Global Operations Planning & CMC Integration team:
  • Minimum of a Bachelor’s degree in Science or Engineering field.
  • 3+ years of project management (MS Project) experience with exposure to 1 or more: Cell Line Development, Drug Substance Development, Drug Product Development, Analytical Sciences.
  • Experience managing a process within a team environment.
  • This role will be based on our main corporate campus in Thousand Oaks, CA and will report to a Project Manager in CMC Life Cycle Management (LCM) in Process Development.
  • The Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing and maintaining project schedules for pipeline projects.
  • This Project Manager will have a significant focus on supporting programs in the late stage phase (pivotal to launch, commercial).
  • Working with the Global 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 collects, digests and assembles 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.

Top Must have Skill Sets:
  • 3+ years of project management experience with exposure to 1 or more: (Cell Line Development, Drug Substance Development, Drug Product Development, Analytical Sciences).
  • Microsoft Project experience.
  • Commercialization process experience (FDA, IND, MA experience) (preferred not required).
  • Soft skills: Ability to foster collaboration and work effectively on cross-functional teams.
  • Experience managing a process within a team environment
Day-To-Day Responsibilities:
  • Work with technical and/or Product Delivery teams creating project schedules that align with PD prioritization.
  • Assist PD in driving decision making using DAI principles (D- Decision maker, A- Advice Giver, I- Informed).
  • Establish and manage collaboration and team sites (i.e. Box, SharePoint).
  • Report project progress to product portfolio management site (i.e. PLM).
  • 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.
  • Facilitate and incorporate lessons learned, best practices, etc.
  • Support business process improvements.
Employee Value Proposition:
Greater knowledge of commercialization of a product, interact with people with different skill sets (networking/cross collaboration) .
Red Flags:
  • Not having minimum education requirements.
  • Music Industry/Media Industry.
Interview Process:
Phone - Skype/Webex 
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 feel free to 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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