Technical Operations Program Manager – Associate Director

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

📋 Description

• Lead an international, cross-functional technical CMC team, along with associated functions such as Quality and affected CMO/CLOs, to produce all necessary technical documentation that supports an approvable NDA Module 3 and translates technical and regulatory strategies into actionable execution.

• Manage projects for all key CMC deliverables, including underlying reports, and coordinate team interactions to ensure that meetings are structured and purpose-driven, document clear decisions and actions, and communicate them to team members and relevant stakeholders, holding team members accountable for the functional delivery of plans.

• Ensure that integrated program plans are established, including cross-functional interdependencies.

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

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

• Develop holistic, scientifically sound, and relevant scenarios as decision proposals at all governance levels.

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

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

• Responsible for the program budget and long-term projections, including budget planning and tracking, and evaluating project resource requirements: identifying resource gaps and working to address them.

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

⛳️ Requirements

• Over 8 years of experience in the pharmaceutical industry.

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

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

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

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

• Identify and assess risks associated with project activities and take appropriate actions to control or mitigate those risks.

• Possess a scientific and technical background in CMC development and manufacturing of drug substances for small molecules and non-sterile products.

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

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

• Proven ability to adapt to an ever-evolving business environment.

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

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunity to expand your knowledge by attending popular conferences.

• Strong emphasis on work/life balance.

• Collaborative and team-oriented work environment.