Manager CMC Program Management (Advanced Therapies)

Role Summary

Dynamic leader with a passion for Chemistry, Manufacturing, and Controls (CMC). Join our CMC Program Management team as a Manager or Senior Manager to shape program strategy, align development goals with operational capabilities, and drive the successful delivery of supply. Lead cross-functional teams and influence key decisions to advance Regeneron programs related to advanced therapies, such as cell and gene therapy and biologics.

Responsibilities

• Drive Strategic Alignment: Lead the development, alignment, and continuous monitoring of integrated CMC program plans to ensure the successful delivery of supply.
• Lead Cross-Functional Teams: Independently manage technical cross-functional teams, representing CMC strategies in forums such as Strategic Program Teams, governance committees, and joint collaboration meetings.
• Engage with Leadership: Collaborate with senior management to develop and execute program strategies across multiple levels of the organization.
• Risk Management: Identify and communicate program risks, progress, and mitigation strategies to ensure program objectives are met.
• Program Monitoring and Reporting: Track progress against program schedules, including acceleration opportunities, financial stage gates, and scenario planning.
• Primary Program Contact: Act as the primary liaison for program-related activities, facilitating the advancement of CMC strategies.
• Develop Tools and Practices: Create and refine program management tools, templates, and best practices to enhance operational efficiency and ensure timely delivery of supply and major market authorization filings.
• Team Leadership: May be responsible for a small team of direct reports.

Qualifications

• Required: BS/BA in Chemistry, Biochemistry, or related field; minimum of 7+ years of industry experience and 5+ years of program management experience, or an equivalent combination of education and experience.
• Sr. Manager: Requires BS/BA and a minimum of 8+ years of industry experience and 6+ years of program management experience, or an equivalent combination of education and experience.
• Hands-on experience in managing programs related to advanced therapies.
• Proficiency in program management tools and data visualization platforms (e.g., Power BI, Tableau).
• Preferred: PMP certification or MBA is a strong plus.

Skills

• Cross-functional leadership and excellent communication, organizational, and problem-solving skills.
• Experience with program management tools and data visualization platforms (Power BI, Tableau).

Education

• BS/BA in Chemistry, Biochemistry, or a related field.

Additional Requirements

• On-site work may be required; please consult with the recruiter for location-specific policies and expectations.