Senior Manager, Cmc Program Management

31953
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This Is What You Will Do
Senior Manager, CMC Program Management is the key program/project and operational excellence leader for the CMC Program Management group for all early and late stage development assets. Senior Manager, CMC Program Management provides global project & program management support to the CMC Teams within Product Development and Clinical Supply (PDCS). Senior Manager, CMC Program Management is responsible for management and delivery of the integrated program timeline, including incorporating deliverables across functions, SMEs and indications. This role will help to drive industry-leading PM best-practices across CMC teams/stakeholders. The CMC Program Management organization is specifically 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

• Responsible for program/project level budgeting and resource management
• Provides key updates on program risks, progress and mitigation plans to management as needed.
• Utilizes project management skills to drive projects to key decision points and milestones. Proactive management of the critical path, operational feasibility of strategic plans, and active program risk management (risk registers, etc), and alignment of operational execution.
• Leads operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.
• Leads generation, alignment and continual monitoring of an integrated CMC program plan across functional lines involved in the development and delivery of supply.
• Monitors and manages progress against the program schedule including acceleration, financial staging opportunities and scenario planning
• 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 in order to facilitate development of options and team recommendations to governance.
• Partners with the team to identify contingency and risk mitigation strategies for project/program level plans
• Drives development of the program CMC goals in partnership with the CMC Lead that enable on-time filings and delivery of clinical supply for all phases of development. Monitors and reports on progress of the program goals.
• Leads cross-functional business integration plans and provides guidance on standardized tools/templates
• Drives execution of the program to achieve delivery and performance goals/objectives without compromising project deliverables or relationships.
• Prepares and manages governance interactions in partnership with the CMC Lead.
• 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.

You Will Need To Have

• 4+ years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or drug development PM.
• Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Must be able to create a highly collaborative and inclusive environment necessary for the cross-functional CMC teams to be effective.
• Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planning desirable.
• Bachelors’ degree in business or scientific discipline required
• Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
• Demonstrated ability to effectively implement the tools and techniques of the program and project management discipline, such as the development and management of multi-disciplinary program level integrated plans, critical path management, project risk management, decision analysis and meeting management.
• Strong track record in executing effective program management skills in cross-functional matrix organizations.
• Proven track record of achievement and delivery of team goals.

We Would Prefer For You To Have

• Preference PM experience from candidate selection to thru approval
• Preference PM experience with small molecules and/or biologics

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion 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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact [email protected]. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.