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.
• Prepare and/or oversee creation of product development plans.
• Perform gap analysis, regulatory requirements, market evaluation, economic feasibility of projects.
• 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.
• Oversee cross functional teams participating and leading multiple project teams and assignments.
• Prepare weekly/monthly reports, agendas, meeting minutes and presentations.
• 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.
• 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, solicit and review proposals and participate in subcontractor selection.
• Execute 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. 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.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
• BS/MS in a scientific related field of study or equivalent.
• 10-15 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.
• 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.
• 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, 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.
• Outstanding demonstrated interpersonal skills a must (both written and oral)
• 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.
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.
Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that "negotiable" is neither salary nor requirements. Salary commensurate with experience.