CMC Project manager - Chemistry, Manufacturing and Controls (JP8220)
Thousand Oaks, CA. (Onsite Essential)
1+ years (with likely extensions)
3 Key Consulting is hiring a Project Manager
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Why is the Position Open?
- 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
Workload is high.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- 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.
- 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
Master's Degree & 3 years of Project Management or Operations experience
Bachelor's Degree & 5 years of Project Management or Operations experience
Associate's degree & 10 years of Project Management or Operations experience
High school diploma/GED & 12 years of Project Management or Operations experience
Employee Value Proposition:
- 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
- No non-scientific degrees.
- No pharma industry experience or otherwise technical laboratory experience.
- Long gap in employment.
Manager will phone screen and schedule WebEx/Skype interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.