Technical Operations Program Manager – Associate Director

📋 Description

• Lead an international cross-functional technical CMC team, along with associated functions such as Quality and impacted CMO/CLOs, to ensure all necessary technical documentation for an approvable NDA Module 3 is delivered and to translate technical and regulatory strategies into actionable execution.

• Manage projects related to all key CMC deliverables, including underlying reports, while coordinating team interactions to ensure meetings are structured and purposeful, documenting clear decisions and actions, and communicating them to team members and relevant stakeholders. Hold team members accountable for the functional delivery of plans.

• Ensure that integrated program plans are established, taking into account cross-functional interdependencies.

• Facilitate the establishment and tracking of program objectives and priorities, monitoring program progress against approved project plans.

• Coordinate the identification and mitigation of program issues and risks, ensuring the creation of risk mitigation plans.

• Develop comprehensive, scientifically sound, and relevant scenarios as decision proposals for all governance levels.

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

• Coordinate the preparation for governance and executive management program presentations in close collaboration with the leadership team.

• Manage the program budget and long-term projections, including budget planning and tracking, while evaluating project resource requirements, highlighting resource gaps, and working to ensure they are addressed.

• Monitor invoices and confirm the execution of corresponding work with the budget owner.

⛳️ Requirements

• More than 8 years of experience in the pharmaceutical industry.

• Substantial hands-on experience in CMC Development and Program/Project Management roles within complex environments.

• Proficiency in collaborating with cross-functional teams in the pharmaceutical sector, ideally in a global context.

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

• Experience in managing detailed program timelines to ensure the timely delivery of key milestones while maintaining oversight of complex project budgets.

• Ability to identify and evaluate risks related to project activities and implement appropriate measures to control or mitigate these risks.

• Scientific and technical expertise in CMC development and manufacturing of drug substances, small molecules, and non-sterile products.

• Proven experience in a cross-functional team setting, with the ability to multitask, prioritize, and make effective decisions.

• High degree of flexibility and effectiveness in cross-functional, international, and cross-regional environments.

• Demonstrated ability to adapt to a constantly changing business landscape.

• Fluent in English; intermediate to advanced 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.

• Focus on maintaining work/life balance.

• A collaborative and team-oriented work environment.