CMC Project Manager

Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Project Manager to join our vibrant team.

Requirements: 

• Manage, coordinate and facilitate the development of the project plan, apply a general knowledge and understanding of the pharmaceutical product development process, particularly as pertinent to biologics and vaccines. Facilitate agreement among team members on the specifics and adequacy of the plan's intermediate goals and objectives and the scheduling for completion of tasks.
• Serve as a resource, apply a general knowledge and understanding of the pharmaceutical product development process, particularly as pertinent to biologics and vaccines, to the design and conduct of projects where the specifics of the project are difficult to determine in advance. Provide recommendations and seek guidance on solutions to advancing the project and/or methods used.
• Work with the team to develop or refine solutions to problems that have significant impact on existing program policies and/or procedures. Anticipate major problems and works with the team to identify future program needs to accomplish the program's mission.
• Monitor and assess the status of projects as they progress; use critical path analysis and/or comparable project management tools to trach progress; monitor deadlines and other benchmarks to ensure that VRC activities are meeting stipulated obligations.
• Identify current or emerging issues affecting the project tasks/activities and/or the accomplishment of its scientific objectives, the sequencing of activities, activity completion times, etc. Disseminate information to the team on the status of the activities, issues/problems, emerging schedule conflicts or opportunities to accomplish the work.
• Apply knowledge of the pharmaceutical product development process to guide team meetings and other interactions in order to clarify critical problems, to develop proposed solutions to problem or issues, to resolve gaps in skills or capacity needed to accomplish the work, to assess options and their impact on the project's costs, quality of work products and timeliness of completion of tasks, etc.
• Facilitate the resolution of conflicts among the team's members who represent different organizational groups with varying interests or concerns that may conflict with the project's timetables, scientific requirements, availability of staff and/or staff time, available resources, sequencing demands, etc.
• Elevate conflicts when necessary to resolve project issues.
• Apply situationally appropriate project management practices to guide teams to successful completion of the project, to keep activities on schedule and to facilitate an effective project that best meets VRC and NIAID goals. Seek out guidance to bring back to the team members collectively or individually.
• Continuously collaborate with the VRC managers, laboratory heads, principal investigators, and other personnel to identify, devise, implements and maintain improvements in the management of vaccine development and manufacturing projects.
• Serve as the team's information manager. Originate, formulate, and disseminate project information, assessments and evaluation to assure that team members are properly apprised of progress and that member's views concerning the project activities are properly disseminated in order to integrate project activities across the team.
• As assigned by the Director of Project Management, manage VRC inter-agency, academic, and industrial agreements, including preparation of work plans, collate technology transfer documentation, organize agreement activities, and provide guidance to VRC on requirements and activities.

Qualifications

• Bachelor's degree in the life sciences. Master's degree, preferred.
• Experience in R&D, product development, or GMP manufacturing is required. Experience advancing Phase I/II products to clinic is preferred.
• Must have experience working in a product development environment, with participation on a cross-functional project team. Greater than 2 years' experience in project management is preferred.
• Must have experience managing both scientific and organizational information.
• Alliance management experience is an asset but not required.
• Possess project management skills and ability to synthesize project workloads for vaccine and antibody-based development from Research through Phase I and Phase I clinical trials.
• Must have experience using project management software and ability to distill highly technical information into effective meeting presentations.
• Government contracting experience (SOW writing, technical oversight, financial planning, etc.) is preferred.