Technical Operations Program Manager – Associate Director

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Lead a global, cross-functional technical CMC team.

• Manage all critical CMC deliverables, including supporting reports.

• Ensure structured and purposeful interactions during team meetings.

• Document and communicate clear decisions and actions to team members.

• Hold team members accountable for the functional delivery of plans.

• Facilitate the establishment and tracking of program objectives and priorities.

• Monitor program progress against sanctioned project plans.

• Coordinate the identification and management of program issues and risks.

• Ensure the implementation of risk mitigation strategies.

• Develop comprehensive, scientifically grounded, and relevant scenarios.

• Oversee the review process for technical documents (e.g., protocols, reports, master and executed batch records, change controls, deviations, etc.).

• Collaborate closely with the leadership team to prepare governance and executive management program presentations.

• Responsible for the program budget and long-term financial projections.

⛳️ Requirements

• Over 8 years of experience in the pharmaceutical industry.

• Significant practical experience in CMC Development and Program/Project Management roles within complex environments.

• Experience collaborating with cross-functional teams in the pharmaceutical sector, preferably on a global scale.

• Exceptional project management skills: Decision- and action-oriented to facilitate swift decisions in alignment with all stakeholders.

• Skilled in organizing, prioritizing, and following up on tasks.

• Proven experience in managing detailed program timelines to ensure the timely achievement of key milestones.

• Ability to identify and assess risks associated with project activities and take appropriate measures to control or mitigate those risks.

• Scientific and technical knowledge of CMC development and manufacturing related to drug substance small molecules and non-sterile products.

• Demonstrated experience working in cross-functional teams with the capability to multitask, prioritize, and make effective decisions.

• High adaptability and effectiveness in cross-functional, international, and cross-regional settings.

• Proven ability to thrive in a dynamic business environment.

• Fluent in English; intermediate to full proficiency in Chinese is an advantage.

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunities to expand your knowledge by attending popular conferences.

• Strong emphasis on work/life balance.

• Collaborative and team-focused work environment.

• Contribute to making a positive difference for ultra-rare disease patients in need of life-saving treatments.