Senior Manager, CMC Program Management at Alexion in New Haven, Connecticut

Job Description:

This is what you will do:



Senior Manager, CMC Program Management is the key program/project and operational excellence leader for all early and late stage development assets. Provides global project & program management support to the CMC Teams within Product Development and Clinical Supply (PDCS). Responsible for management and owning the integrated program timeline, including incorporating results across functions, SMEs, and indications. This role will help to drive industry-leading PM best-practices across CMC teams/partners. Responsible for program timelines as it relates to PDCS and other critical business partners (RA-CMC, QA, Operations, et al) as well as reporting, risk and budget management, scheduling, facilitating meetings and taking minutes, action items/follow-ups, and other PM-related duties.



You will be responsible for:

• Drives development CMC goals in partnership with the CMC Lead that enable timely filings and delivery of clinical supply for all phases of development. Monitors and reports on progress of the program goals.


• Leads generation, alignment, and continual monitoring of an integrated CMC program plan across functional lines involved in the development and delivery of supply.


• Leads cross-functional business integration plans and provides guidance on standardized tools/templates


• Prepares and manages governance interactions.


• Provides key updates on program risks, progress and mitigation plans to management as needed.


• Program/project level budgeting and resource management


• Provide robust program management tools, templates, and practices to ensure delivery of supply and major market authorization filing via cross functional alignment and proactive problem solving.


• Drives program execution to achieve delivery and performance goals/objectives without compromising project results or relationships.


• Leverage project management skills to drive projects to key decision points and achievements. Proactive management of the critical path, operational feasibility of strategic plans, and active program risk management (risk registers, etc.), and alignment of operational execution.


• Monitors and leads progress against the program schedule including acceleration, financial staging opportunities, and scenario planning


• Leads operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.


• Partners with the team to identify contingency and risk mitigation strategies for project/program level plans


• Defines and aligns program messages and major communications (internal and external) with the CMC lead and CMC team. Responsible for ensuring effective, accurate and timely communication of program information to facilitate development of options and team recommendations to governance.

You will need to have:

• Bachelors' degree in scientific field required


• 5+ years proven success managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or drug development PM.


• Build a highly collaborative and inclusive environment for the cross-functional CMC teams to be effective.


• Proven success in implementing effective program management skills in cross-functional matrix organizations.


• Exceptional knowledge of program and project management and its application to drug development to deliver time, cost, quality, and risk management to teams!


• Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.


• Effectively implement the tools and techniques of the program and project management field, such as the development and management of multi-disciplinary program level integrated plans, critical path management, project risk management, decision analysis and meeting management.


• Proven record of achievement and delivery of team goals.

We would prefer for you to have:

• PM experience from candidate selection to thru approval


• PM experience with small molecules and/or biologics


• Experience with Smartsheet, Power BI and other reporting/metrics capabilities


• Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planning

Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.



Date Posted

12-Sep-2024



Closing Date

21-Nov-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.


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