Project Manager III   

We are looking for an experienced, self-motivated Project Management professional reporting directly to the Sr. Project Manager, to provide project management for gap filling NIH contracts for infectious diseases and microbicide projects.  The Project Manager will perform feasibility assessments, prepare product development plans and lead cross-functional project teams involved in cGMP manufacturing, preclinical testing and regulatory submissions as well as responsible for tracking deliverables and costs for reporting to client and our executive management

MAIN ACCOUNTABILITIES

• Oversee all aspects of developing feasibility assessments of infectious disease vaccine and biologics projects.  This includes product history, product design, seed materials, manufacturing feasibility, viral clearance, regulatory history and intellectual property searches.  
• Prepare and/or oversee creation of product development plans.
• Perform gap analysis, regulatory requirements, market evaluation, and economic feasibility of projects. 
• Manage in-house and outsourcing for preclinical biologics development projects that may include the following: GMP contract manufacturing, analytical testing, regulatory submission preparation and performance of preclinical toxicology services.
• Perform risk assessments and propose risk mitigation strategies.
• Oversee cross-functional teams participating and leading multiple project teams and assignments.
• Prepare monthly reports and concept reports, agendas, meeting minutes and presentations.
• Maintain and track cost review summaries of client deliverables. Routinely prepare report summaries updating our Executive Management.
• Track and manage all aspects of project budgets. Identify potential risks and gaps associated with costing (labor, subcontracts and budgets).
• Manage financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition and communicating financial summaries.
• Determine activities and resources required and prepare a detailed scope of work specific for each project. 
• Define, track and maintain accountability for milestones, schedules and timelines. 
• 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. 
• Identify areas where subcontractors are required, reviewing proposals and participate in selecting subcontractor selection
• Carry out the project plan as defined by the scope and activities; evaluate overall project performance on a regular basis; manage subcontractors; utilize a shared database to store all information regarding the products prepared under contract.
• Communicate all project issues/needs to assigned Principal Investigators and client/stakeholders.
• Ensure that project priorities and decisions are communicated, are consistent between teams, and support the overall program. 

KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:

• MS in a scientific related field of study or equivalent; advanced degree or MBA is a plus
• 15-20 experience in a biotechnology research/pre-clinical process or drug development setting for infectious diseases.  (Phd w/minimum 10 years experience acceptable).
• A combination of experience that includes hands on execution of cGMP manufacturing, conducting preclinical studies and/or preparing regulatory document preparation required, preferably in a bio defense setting.  There is preference for candidates with direct experience in managing government contract reporting deliverables with fiscal responsibility.
• Strong preference for candidates with direct experience at a Contract Research Organization (CRO) that offers GMP, GLP, and/or toxicological pre-clinical services for product development efforts.
• Experience with managing and overseeing subcontractors supporting commercial or government clients preferred.
• Ideal candidate will have experience managing financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition and communicating financial summaries. 
• Proficiency using project management tools to oversee all elements of project lifecycle including scheduling/planning, meeting coordination, tracking of deliverables, reporting to stakeholders and risk mitigation.
• Demonstrated ability to work as a strong contributor in a team environment on complex projects
• Proven multi-tasking skills able to handle multiple projects simultaneously; ability to motivate teams, work within aggressive timelines collaboratively with cross-functional departments
• Proven and demonstrated computer (PC) and software skills including MS Office Suite programs, Internet, email systems a must.  Experience with Microsoft Excel and Microsoft Project is required.
• Demonstrated ability to work as a strong contributor in a team environment and able to interaction with all echelons of management and staff.
• Must be detail-oriented, dependable, motivated, ability to work with minimal supervision; Proven multi-tasker able to handle multiple projects well;
• Strong/effective interpersonal skills, both communication and written & able to communicate effectively with all echelons of Management and staff.
• Must be able to lift up to 15 lbs with or without reasonable accommodations.