The Project Manager II plays a key role in facilitating and monitoring the execution of all aspects of government and commercial contract laboratory activities associated with preclinical and clinical development programs. The Project Manager will perform project scope development, manage cGMP projects, create comprehensive schedules, monitor deliverables and payment milestones, contribute to feasibility assessments, and prepare product development plans.

• Oversee all aspects of managing immunological and/or virology research/manufacturing cGMP production projects as they move through pre-clinical and clinical phases of product development.
• Manage outsourcing and 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.
• Perform risk assessments and propose risk mitigation strategies for the project.
• Prepare weekly/monthly reports, agendas, meeting minutes and presentations.
• Maintain and track cost review summaries of client deliverables. Track and manage all aspects of project budgets. Identify potential risks and gaps associated with costing (labor, subcontracts, and budgets).
• 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 areas where subcontractors are required, solicit, and review proposals and participate in subcontractor selection. Once selected, manage the subcontractor agreement.
• Communicate all project issues/needs to both internal and external stakeholders, including ABL Executive Management through the IPR process.
• Identifies and contributes to internal initiatives for continuous improvement of ABL business processes and project delivery and profitability.
• May train new project managers on tactical responsibilities of the job.
• Other duties as assigned.

• Bachelor’s degree
• A minimum 3-6 years of experience in a biomedical development and clinical process setting for infectious diseases.  Previous hands on working knowledge of process development and cGMP manufacturing for biologics.
• Ideal candidate will have experience managing financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances,
• reporting revenue recognition, preparing technical progress reports 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.
• Strong/effective interpersonal skills, both oral and written communication, and be able to communicate effectively with all echelons of Management and staff.
• Proven and demonstrated computer (PC) and software skills including MS Office Suite programs, Internet, email systems.  Experience with Microsoft Excel and Microsoft Project.
• Must be detail-oriented, dependable, and motivated, ability to work with minimal supervision.
• Possess managerial courage
• Takes initiative
• Works well with all types of people
• Remains calm under pressure