Job Title: Senior Manager, CMC Program Management
Location: New Haven, Connecticut, United States
Job ID: R-224802
Date posted: 17/04/2025
About the Company:
Alexion, AstraZeneca Rare Disease is a global leader in the development of life-changing therapies for rare diseases. The company is committed to improving patient outcomes through innovation, particularly in the fields of hematology, nephrology, and other rare conditions. Alexion is focused on delivering excellence across all stages of drug development and manufacturing.
Job Responsibilities:
Program & Project Management Leadership:
Lead the development of program CMC goals, ensuring on-time filings and clinical supply delivery for all development phases
Manage and deliver integrated program timelines across functions and business partners
Provide guidance on standardized tools/templates for cross-functional business integration plans
Governance and Risk Management:
Prepare and manage governance interactions in partnership with the CMC Lead
Provide updates on program risks, progress, and mitigation strategies to management
Proactively manage critical path, risk registers, and operational feasibility of strategic plans
Budget and Resource Management:
Responsible for program/project-level budgeting and resource management
Monitor and manage progress against program schedules, including financial staging and acceleration opportunities
Cross-Functional Collaboration & Communication:
Ensure effective and timely communication of program information to internal and external stakeholders
Partner with the team to identify contingency plans and risk mitigation strategies
Program Execution & Delivery:
Drive execution of programs to meet performance goals/objectives without compromising project deliverables
Lead operational project management for CMC alliance or co-development programs, contributing to steering committees and sub-committees
Required Qualifications:
Education:
Bachelor’s degree in a scientific discipline
Experience:
5+ years of experience managing and leading complex projects/programs in the biopharmaceutical industry, ideally in CMC or drug development
Proven ability to manage cross-functional matrix teams and ensure program delivery
Skills and Abilities:
Strong program management skills with a focus on time, cost, quality, and risk management
Experience creating and managing complex program plans with global teams
Familiarity with the application of program management tools, including integrated plans, critical path management, and project risk management
Preferred Qualifications:
Experience:
Experience managing programs from candidate selection to approval
Familiarity with small molecules, peptides, or biologics
Tools & Technologies:
Experience with Smartsheet, Power BI, and other reporting/metrics capabilities
Knowledge:
Understanding of clinical and commercial manufacturing and distribution issues impacting project strategy and planning
Why Join Alexion:
Lead impactful CMC programs in the development of life-changing therapies
Join a global, inclusive team dedicated to innovation and patient care
Take part in industry-leading drug development practices and cross-functional collaboration
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