Bilingual (English & Chinese) Project Coordinator/Manager - CDMO Service

uBriGene•Germantown, MD

About The Position

We are seeking an individual with a strong background in viral vector production and/or project management. This position reports to VP of Commercial Strategy. Provide project management support to CMC team members including PD, TT and GMP teams in their execution of activities including manufacturing and release of drug substance and drug product, manufacturing process improvements and validation, analytical method development, transfer and validation, and shipping studies. Serve as the primary liaison between uBriGene and clients on CMC activities for the client projects. Collect updates on all CMC activities in the MS Project file on a monthly basis to update % completion or new dates. Schedule, conduct, and draft minutes for PD, TT and GMP team on respective client projects to ensure regular, efficient team, and stakeholder communication. Facilitate robust communication within PD, TT and GMP teams to ensure all functions are aware of the schedule, changes in strategy and impacts to risks and resources. Hold team members accountable for on-time completion of tasks or milestones. Performs critical path analysis and supports scenario planning for CMC deliverables. Provide project coordination and communication, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings. Support writing, review, and schedule of CMC related regulatory documents and health authority interactions. Assist in preparing presentations, updating corporate project plans, etc. Other responsibilities as needed.

Requirements

B.S. or MS. in engineering or biological sciences degree is required
> 3 years of experience in biologics manufacturing, preferably in viral vector production
Proven experience organizing, planning, and executing large-scale projects from vision through implementation
Experience using project management tools (project scheduling and resource management), such as MS Project.
Proven analytical, conceptual and problem solving skills are required to evaluate business problems and apply knowledge to identify appropriate solutions.
Exceptional team building and stakeholder relationship management skills are required, with the ability to establish rapport, persuade and effectively negotiate with senior management, key stakeholders and functions.

Nice To Haves

Previous project management experience in the biologics production is preferred but not required.
Bilingual skills in English and Chinese are preferred.

Responsibilities

Provide project management support to CMC team members including PD, TT and GMP teams in their execution of activities including manufacturing and release of drug substance and drug product, manufacturing process improvements and validation, analytical method development, transfer and validation, and shipping studies.
Serve as the primary liaison between uBriGene and clients on CMC activities for the client projects.
Collect updates on all CMC activities in the MS Project file on a monthly basis to update % completion or new dates.
Schedule, conduct, and draft minutes for PD, TT and GMP team on respective client projects to ensure regular, efficient team, and stakeholder communication.
Facilitate robust communication within PD, TT and GMP teams to ensure all functions are aware of the schedule, changes in strategy and impacts to risks and resources.
Hold team members accountable for on-time completion of tasks or milestones.
Perform critical path analysis and support scenario planning for CMC deliverables.
Provide project coordination and communication, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
Support writing, review, and schedule of CMC related regulatory documents and health authority interactions.
Assist in preparing presentations, updating corporate project plans, etc.
Other responsibilities as needed.