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Project Management

For every project, a Project Manager is assigned as a single point of contact to accelerate execution with all external parties. Our experienced project management team have efficient and well-practiced project management systems that provide precise communication throughout the full project lifecycle.

Scope of Work

  • Manage project timeline to coordinate all activities within Bioworkshops.

  • Run program of core team meetings, joint project development team meetings, and joint development committee meetings.

  • Standard project reporting includes weekly written update, monthly  written progress reports, monthly meetings, written technical reports for development milestones, and rapid escalation of key issues to customers. Project reporting format and frequency can also be customized according to project and client requirements.

Project Process Management

  • Initiating

    Customer requirement confirmation--Project charter

    Technical document /Material transfer

    Establishment of stakeholder list

    Kick-off meeting

  • Planning

    Detailed project planning

    Budget allocation

    Gap analysis and risk identification

    Project folder establishment and permission assignment

  • Executing

    Project plan implementation

    Problem and risk solution

    Decision gates on key nodes

    3rd party supplier management

    Timely communication with Client

  • Monitoring & Controlling

    Cost, schedule, quality deviation Management

    Meeting and reporting: Weekly/Monthly report Biweekly meeting Timely special meeting

    On-site inspection

    Customer complaint management

  • Closing

    Internal acceptance of products and documents

    Client acceptance of products and documents

    Experience summary

    Balance settlement

To ensure information security, only the person responsible for the project has access to the data

Project Management Team

Bioworkshops will assign a dedicated Project Manager to each project based on the team members' technical expertise and project needs to ensure that customers’ needs are fully met. The Project Manager will act as a single point of contact for all external parties to accelerate the execution of the project, ensuring precise communication throughout the entire process. Our rigorous information security controls and modern IT infrastructure assure efficient, secure, and confidential delivery of the project.

Our project management team has full lifecycle project management experience for antibody drug development covering early CMC research, IND filing, clinical research, late-stage CMC research, NDA/BLA filing, product launch, and post-market changes for China, the United States, Europe, and Australia.

They use their practical experience to optimize the project plan for each project, including standardized PMP® risk management processes, to expertly coordinate all CMC deliverables, regardless of whether the scope is for initial IND filing or commercial-stage production.

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