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GMP Project Manager

Project Manager :

The main responsibilities will include but are not limited to:

• Oversee all aspects of managing process development and cGMP production projects for viral, mammalian and bacterial based products of clinical application as vaccines and biologics.   Have a strong working knowledge of process development and laboratory techniques associated with state of the art technologies.
• Manage in-house projects for preclinical biologics/vaccine development projects that may include the following: process development, cGMP contract manufacturing, analytical testing, and CMC sections submission preparation.
• Develop full-scale project plans/schedules with work breakdown structure.  Identify and manage project dependencies and critical path and go/no-go decisions.   Identify risks and create mitigation strategies. Support and lead the team through gap analysis, regulatory requirements, market evaluation, economic feasibility of projects.  
• Perform risk assessments and propose risk mitigation strategies for the project.
•  Oversee cross functional teams participating and leading multiple project teams and assignments.
• Prepare weekly/monthly reports, agendas, meeting minutes and presentations. Track and sloe out action items with team members.
• Maintain and track cost review summaries of client deliverables. Routinely prepare report summaries to update Executive Management.
• Track and manage all aspects of project budgets. Identify potential risks and gaps associated with costing (labor, subcontracts and budgets).  
• Identify and report scope changes.  Develop costing assumptions for business development.
• Manage financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition and communicating financial summaries.
• Define, track and maintain accountability for milestones, schedules and timelines.  
• Identify areas where subcontractors are required, solicit and review proposals and participate in subcontractor selection. Manage subcontractors.
• Communicate all project issues/needs to assigned Principal Investigators and client/stakeholders. Provide frequent presentations on project status to executive management.
• Ensure that project priorities and decisions are communicated, are consistent between teams, and support the overall program.
• Utilize ERP to record, track and report project status to Executive management.
• Contribute to internal initiatives for continuous improvement of business processes and project delivery and profitability. Change management and training of colleagues within and outside the department is expected for improved performance on projects.

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