Technical Operations Program Manager – Associate Director
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Job Description
CMC / Technical Operations Program Manager leading international cross-functional teams to deliver technical documentation for drug approval. Overseeing program budgets and timelines while coordinating reviews of essential technical documents.
Responsibilities:
- 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
Requirements:
- > 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.
Benefits:
- 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
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