Our client, a leading pharmaceutical company, is hiring a Project Manager/CTDO LIMS/SMART QC consultant on a contract basis.
This position will support Quality Control (QC) in project management for the CELabs LIMS and SMART QC systems. The role will report to the global QC Systems and Services function. The Project Manager will develop project plans, develop, and manage timelines, identify, and respond to critical path barriers. The role will require significant collaboration across internal and external functions to ensure on-time release of final product. Ideal candidate will have demonstrated ability to balance multiple competing priorities, manage projects. The role is required to work in a cross-functional and dynamic setting where project assumptions and scenarios may change and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization.
Work scope will include operations excellence, continuous improvement projects and capacity expansion projects in support of commercial and clinical QC. This role will work with project management and subject matter experts across multiple sites including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, PMO, IT, EHS, Finance, Regulatory, and Clinical and Commercial Operations.
Knowledge, Skills, and Abilities:
• Ability to work independently
• Ability to matrix manage cross functional teams
• Must be competent in Project Management tools and methodologies
• Excellent organizational and time management skills
• Experience with regulated GMP environment for manufacturing (Biologics or Cell Therapy experience is a plus).
• Strong analytical, problem-solving, and critical thinking skills
• High attention to detail skills
• High organization skills with ability to multi-task several objectives in parallel
• People and project management skills
• Advanced proficiency in MS Office applications
• Proficient written and verbal communication skills
• Ability to develop and provide training on various functions
Education and Experience:
• Bachelors degree required
• 5+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
• An equivalent combination of education, experience and training may substitute.
Preferred but not required:
• PMP certification desirable.
• Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization.
DUTIES AND RESPONSIBILITIES:
• Manage multiple, low to medium complexity process improvement and/or Technical projects and timelines.
• Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items.
• Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards
• Develop critical path analyses with the team to understand risks and opportunities within project timelines and help develop contingency plans
• Responsible for the preparation of routine status reports and communicate project progress to stakeholders
• Lead operational projects including weekly QC LIMS huddles, QC CTDO LIMS planning and management and monitoring tools
• Ensure that team recommendations related to project direction and timelines which need endorsement by governance teams are planned for review at appropriate milestones
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
• Develop and implement KPI and reporting capabilities
• Collaborate with IT Business Partners in support of modeling, scheduling simulation implementations and automated scheduling tools