Lead an international cross-functional technical CMC team
Project manage all key CMC deliverables, incl underlaying reports
Coordinate team interactions ensuring team meetings have structure and purpose
Documents clear decisions/actions and communicates them to team members
Holds team members accountable for functional delivery of plans
Facilitate the setting and tracking of program objectives and priorities
Monitors program progress against approved project plans
Coordinates the identification and mitigation of program issues and risks
Assures risk mitigation plans
Build holistic, scientifically sound and relevant scenarios
Coordinate the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)
Coordinates the preparation for governance and executive management program presentations in close collaboration with the leadership team
Responsible for program budget and long-term projections

8 years of pharmaceutical industry experience
Significant hands-on experience in CMC Development and Program/Project Management roles in complex environments
Experience in working with cross-functional teams in the pharmaceutical industry, preferably in a global setting
Excellent Project management skills: Decision
and action-oriented to facilitate quick decisions in alignment with all stakeholders
Ability to organize, prioritize and follow-up
Experience in managing detailed program timelines to ensure timely delivery of key milestones
Identify and evaluate risks associated with project activities and take appropriate actions to control or mitigate risks.
Scientific and technical background of CMC development and manufacturing in drug substance small molecule, no-sterile products.
Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker
High level of flexibility and effectiveness in cross-functional, international, and cross-regional environments.
Proven ability to adapt to an ever-changing business environment.
Fluent in English, intermediate to full proficiency in Chinese is a plus.

Competitive compensation for your work
Generous time off policy
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Technical Operations Program Manager – Associate Director

Key skills