Aditi Consulting is a company offering consulting and recruitments for business transformation with leading technologies. They help business organizations to accelerate business growth through premier technological solutions, project management, and digital transformation. The company was founded in 1994 by Pradeep Singh. The corporate head office is located in Bellevue, Washington, United States. Aditi Consulting has partnered with more than 500 companies as an E-commerce cloud platform firm and telecom company to solve business problems in large and medium enterprises across retail, digital, healthcare, finance, telecom, and technology industries. Aditi opens up a world of opportunity and rewarding careers for those who are focused on results, a team player, and hungry for success, as the right place for everyone.
Title: CMC project manager
Location: thousand Oaks,CA
Duration: 12 months contract to hire
Ideal candidate- Experience in Process Development space specifically large molecule space. Prior project management skills/experience working with cross functional teams. Technical degree within life sciences or engineering- BS. Overall 10 years working experience.
This role will be based in Thousand Oaks, CA and will report to Sr. 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 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
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
- 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
We are a technology solutions company helping organizations accelerate their business innovation and growth through project and talent solutions.