The Project Manager for LIMS is a role within the Technology Program Management Office reporting directly to the Senior Director, DTE Portfolio Manager, with dotted line matrixed reporting to the Director, Business Engagement & Technology.
The Project Manager will have execution delivery responsibilities for the LIMS Deploy Project for Cell & Gene Therapies.
Building on the current LIMS strategy, the team will deliver an implementation project to enhance, test and deploy the LabVantage GxP LIMS for the Cell & Gene Therapies (VCGT) Cell Manufacturing QC and Device Manufacturing QC labs.
The Project Manager will be charged with hands-on management of all PMO activities and ensuring accurate status reporting for the VCGT LIMS Deployment workstreams and driving the project outcomes.
The Project Manager, VCGT LIMS Deployment, is required to have relevant PMO-related experience specifically in LIMS implementation in a pharmaceutical GMP environment.
This experience will be critical in understanding both the process challenges and the technology being implemented, which will help the Project Manager facilitate successful delivery outcomes.
The Project Manager will work closely with the Director, Business Engagement & Technology, and the cross-functional LabVantage GxP LIMS team.
The Project Manager will ensure that the project is in alignment with other inter-dependent projects, programs and stakeholders.
The Project Manager will be responsible for hands-on execution of the VCGT LIMS Deployment Project for VCGT. This includes responsibility for :
- Program and Workstream Governance
- Scope Management
- Schedule Management
- Resource Management
- Financial Management
- Risk and Issue Management (including cross-functional impact assessment / mitigation)
- Dependency Management (both within the program and externally)
- Integration Management
- Stakeholder Management
- Communications and Change Management
- Business Adoption and Acceptance / Client Satisfaction
The Project Manager should expect to be heavily involved in presenting and monitoring status, anticipating challenges, unblocking issues, managing dependencies and providing business sponsor and stakeholder transparency for the program through accurate and timely management reporting.
The Project Manager will also be responsible for collaboration with project managers from external consulting teams to ensure successful joint outcomes and accurate management reporting.
Required Knowledge, Skills and Experience :
Knowledge and Experience
- A minimum of 8 years of experience in Project Management
- Demonstrated proficiency in managing large-scale, complex projects
- Training and experience in Agile practices
- Experience working specifically on LIMS projects, including :
- experience in the design / build / test / deploy of a commercial off-the-shelf LIMS in a pharmaceutical or biotechnology GXP environment
- experience managing computer system validation activities and deliverables for a configurable, commercial application
Leadership
- Demonstrated leadership presence and drive
- Excellent presentation skills and ability to clearly and succinctly express ideas
- Experience facilitating project meetings and effectively and respectfully holding team members accountable for status, deliverables and the timely escalation of blockers
- Unfailing commitment to representing project status in an accurate and timely manner, weekly or in near real time when changes occur
- Successful track record of managing collaborative projects with vendors and packaged software
Collaboration
- Exemplify a highly collaborative mindset and actively facilitate team communication
- Build strong relationships with peers and colleagues across the Technology organization, and with key VCGT business clients and third party consultants
- Actively anticipate, track and plan for risks and issues, dependencies, resourcing and contingencies
- Communicate status, risks and issues in a direct and timely manner
- Escalate issues in a manner that is effective and direct
Innovation
- Demonstrate an analytical, objective, and strategic mindset and a drive to learn new technologies
- Analyze processes and systems, identifying potential for change
- Possess an understanding of technology solutions implemented in the past
Skills / Tools
- Excellent communication skills, both verbal and written
- Experience practicing project feature prioritization and backlog grooming methods
- Experience with Project and Portfolio Management (PPM) tools and reports
- Demonstrate ability to accurately track and forecast financials and provide accrual information to Finance
- Understanding of the principles of finance and cost benefit analysis (e.g., capitalized, amortized and expensed costs, opportunity costs, soft and hard dollar benefits, payback, ROI, ROE, NPV, etc.)
Preferred Knowledge, Skills and Experience :
- Biopharmaceutical or biotechnology experience
- Experience with high-growth stage companies
- Agile CSM, PSM or similar certification and hands-on experience
- PMP or Prince2 certification
- Experience working specifically on enterprise LIMS or other large lab application projects (commercial LIMS such as LabVantage, LabWare, SampleManager) including computer system validation processes and system life cycle deliverables
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