The main responsibilities will include but are not limited to:
• Serve as primary point of contact between subcontractors, government representatives and internal clients.
• Manage outsourcing projects for preclinical biologics/vaccine development projects that may include the following: process development, cGMP contract manufacturing, GLP tox studies, analytical testing, and CMC sections submission preparation.
• Manage financial goals by forecasting requirements, tracking annual budgets, scheduling expenditures, analyzing variances, reporting revenue recognition and communicating financial summaries.
• Create comprehensive schedules, monitor deliverables and payment milestones for multiple government contracts.
• Contribute to feasibility assessments and prepare and/or oversee product development plans.
• Perform gap analysis, risk assessments and propose risk mitigation strategies.
• 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.
• Ensure that project priorities and decisions are communicated, are consistent between teams, and support the overall program.
• Evaluate performance of current budget tracking system and work with internal parties to suggest and/or implement new procedures or tools to streamline the process
• Other duties as assigned.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
• BS/MS in a scientific related field of study or equivalent.
• 5+ experience in a biotechnology research/pre-clinical process or drug development setting. A combination of experience that includes direct involvement on toxicology studies, and authoring preclinical study protocols is preferred. 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 Manufacturing Organization (CMO) that offers GMP and process development services.
• Proven aptitude for project management tools. Project Management Certification a plus.
• Knowledge of general accounting principles is required, 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. .
• Experience with managing and overseeing subcontractors supporting commercial or government clients preferred.
• 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.