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.