Manager, CMC Program Management

About the Role

Key Responsibilities

• Leverage previous experience within CMC product development and commercialization to integrate between multiple functional areas, including Technical Development, Manufacturing, Regulatory, Quality, and Supply Chain.
• Oversee the CMC project plan to align with program goals and ensure timely execution.
• Develop project plans that integrate cross-functional inputs and support strategy execution.
• Manage the risk register by identifying risks and implementing mitigation strategies.
• Ensure action items from team meetings are completed, upholding team accountability.
• Organize and lead team meetings, producing concise materials to communicate key points.
• Provide data analysis to support strategic decisions and direction setting.
• Track project milestones, report progress, and keep stakeholders informed.
• Formulate plans for risk mitigation and scenario planning for potential challenges and opportunities.
• Oversee project budgets, ensuring alignment with financial objectives.
• Lead Project Management processes, including technical and reviews, goal setting, and commercialization strategies.
• Contribute to the enhancement of Project Management practices for organizational effectiveness.

Requirements

• Bachelor's or Master's in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline.
• 8 years of relevant experience with a Bachelor's degree or 6 years of relevant experience with a Master's degree.
• Strong project management skills with an agile approach to system development.
• Strong communication skills.
• Experience in risk register maintenance and action log management.
• Proficiency in facilitating meetings and drafting presentation materials.
• Ability to lead contingency planning and scenario analyses.
• Advanced PowerPoint and SmartSheet or MS Project skills.
• Evidence of problem-solving and innovative thinking to deliver creative solutions.
• Ability to work collaboratively on multiple projects concurrently in a fast-paced environment.
• Excellent organizational, communication, and analytical skills with a keen attention to detail.
• Outstanding interpersonal skills to form and maintain strong relationships.
• Willingness and dedication to go above and beyond in pursuit of team goals.

Nice to Have

• Project Management Professional (PMP) certification.
• Previous experience with CMC product development and commercialization.
• Familiarity with CMC technical processes and the overall drug development process.
• Experience in risk register maintenance and action log management.
• Advanced PowerPoint and SmartSheet or MS Project skills.
• Evidence of problem-solving and innovative thinking to deliver creative solutions.

Qualifications

• Educational background in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related field.

Benefits & Perks

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs.
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Lifestyle Spending Accounts to personalize your well-being journey.
• Family planning and adoption benefits.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities.
• Location-specific perks and extras.