Job Summary

This position is responsible for facilitating CMC activities for the large molecule projects in China. This individual will report to the Head of CMC Management and serve as the CMC PJ Lead of the large molecule projects. Roles include, but are not limited to, supporting the overall CMC strategies within projects, managing project teams, overseeing the China CMC sub-team in tracking project status, assessing project issues, and developing resolutions to achieve goals of IND/NDA filing and stakeholder satisfactions.

Responsibilities

1.CMC management

Develop a clear CMC strategy and communicate well with the global CMC Team members, from an overall optimization perspective with in-depth CMC knowledge. Consider Plan B development from a risk management perspective. Be proactive in resolving issues and challenges encountered during the assignment. Responsible for the overall status of the project with respect to budget, timeline, and achievement of defined milestones.

Provide leadership in the project/development team, as a Matrix Lead. Lead special project(s)/committee(s) that are critical to Compound development and/or milestones.

As the key project representative, prepare and present comprehensive internal and external presentations and decision memos, encompassing all relevant areas of the project.  

2. Regulatory Affairs

Actively manage CMC aspects of regulatory submissions (IND, NDA, etc.) and interactions with health authority. Work closely with RACMC to schedule regulatory affairs-related CMC tasks for clinical trial application. Collaborate with RACMC to coordinate the content and timing of consultation to authority. Review and provide technical comments to regulatory related documents.

3. Cross-functional communications

Ensure effective communication and collaboration between all relevant functions and third parties. Establish good working relationships with internal and external stakeholders, e.g., SMEs, CDMOs. Participate in project teams as a representative for CMC related tasks, accurately assess project status and provide appropriate solutions to any issues through close communication with global CMC management and local China project members. Interfacing with various site locations globally. Establish a culture of open communication and effective collaboration, driving consensus but willing to take a stand when necessary.

Qualifications:

• Master or PhD degree in Life Sciences, Chemistry, Pharmacy, or related field.

• Minimum 5 years of experience in the large molecule area of the pharmaceutical industry with at least 2+ years within CMC Development.

• Extensive knowledge of all aspects of mAb or ADC CMC is preferred.

• Basic knowledge about GMP requirements within (bio-)pharmaceutical production.

• Experience in process/product development, analytical development, and/or manufacturing activities.

• Demonstrated project experience in IND and NDA filings and familiarity with relevant NMPA, FDA, and EMA regulations, preferably with NDA or BLA/MAA submission experience in oncology area.

• Experience in interacting with NIFDC is preferred.

• Strong project management, time management, collaboration, presentation, and negotiation skills.

• Ability to prioritize and manage multiple activities and priorities simultaneously.

• Excellent interpersonal and communication skills with the ability to build strong rapport with all levels of the organization. Experience in leading and communicating with international teams is a plus.

• Strong verbal and written communication skills in English.