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

uBriGene Biosciences Inc.; Germantown (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

uBriGene Biosciences Inc. seeks an experienced project manager with a strong background in viral vector production to support the CMC team and coordinate with PD, TT and GMP groups.

This role acts as the main client liaison, tracks progress in MS Project, and drives on-time completion of milestones. Responsibilities include facilitating cross-functional communication, preparing regulatory documents, and supporting health authority interactions.

Qualifications

• B.S. or MS in engineering or biological sciences required.
• >3 years of experience in biologics manufacturing, preferably in viral vector production.
• Project management experience in biologics production preferred but not required.
• Proven ability to organize, plan and execute large-scale projects from vision to implementation.
• Experience using project management tools such as MS Project.
• Strong analytical, conceptual and problem-solving skills.
• Excellent team building and stakeholder relationship management, with persuasion and negotiation abilities with senior management.
• Bilingual in English and Chinese preferred.

Responsibilities

• Provide project management support to CMC teams including PD, TT and GMP for drug substance/product manufacturing, process improvements, validation, and shipping studies.
• Act as primary liaison between uBriGene and clients on CMC activities for client projects.
• Collect monthly updates on CMC activities in MS Project to track completion and dates.
• Schedule, conduct, and draft minutes for PD, TT and GMP meetings to ensure clear communication.
• Facilitate cross-functional communication to align schedules, strategy changes, risks and resources.
• Hold team members accountable for on-time task completion.
• Perform critical path analysis and support scenario planning for CMC deliverables.
• Coordinate and communicate in technical calls and meetings; prepare agendas and minutes; track actions.
• Assist in preparing regulatory documents and health authority interactions.
• Support in preparing presentations and updating corporate project plans.

Skills

Viral vector production

Project management

MS Project

Biologics manufacturing

Stakeholder management

Team coordination

Analytical thinking

Communication

Bilingual English/Chinese

Education

B.S. or MS in engineering or biological sciences

Tools

MS Project

Job description

Position Summary

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

II. Requirements

Education, Experience, and Skills

• B.S. or MS. in engineering or biological sciences degree is required


• > 3 years of experience in biologics manufacturing, preferably in viral vector production


• Previous project management experience in the biologics production is preferred but not required.


• 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.


• Bilingual skills in English and Chinese are preferred.

uBriGene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.