Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3
Project manage all key CMC deliverables, incl underlaying reports
Coordinate team interactions ensuring team meetings have structure and purpose
Assure integrated program plans are in place including cross-functional interdependencies
Coordinates the identification and mitigation of program issues and risks
Coordinating the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)
Responsible for program budget and long-term projections – budget planning and tracking

10 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
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