Senior Manager/Associate Director, CMC Project Management at Acceleron Pharma
Cambridge, MA, US
Acceleron is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in Charcot-Marie-Tooth disease, and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

What’s in it for you?

We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to be part of our success. In this role, you will provide project management expertise to ensure CMC activities are executed in coordination with and support of the integrated product development plan for clinical-stage and predevelopment-stage biologics programs at Acceleron.  Reporting to the VP, Program Management, you will apply your expertise and understanding of CMC functions within drug development to organize key CMC activities.  You will work closely with technical subject matter experts and program-specific CMC leads, ensuring adherence to CMC-specific program timelines in accordance with the overall program goals and timelines, scope, budget and risks.  This role will also entail external vendor management and relationship-building, including leading technology transfer teams to enable efficient and effective manufacturing, testing, and other CMC operations.

What will you be doing? 
  • Reporting through the Program Management team and supporting the Technical Operations, Quality and Regulatory-CMC teams in the management of cross-functional CMC efforts, including creation and execution of strategic CMC development plans and timelines
  • Fostering strong relationships with team members and functional line managers, supporting project-related communications and issue identification and management
  • Facilitating internal CMC decision-making processes and preparing regular updates for senior management and Program Leaders
  • Managing technology transfer team meeting operations (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items)
  • Coordinating internal program timelines and priorities with your counterparts at Contract Manufacturing Organizations
  • Maintaining program-related CMC-specific documentation, including, but not limited to, program plans, timelines, and budget
  • Proactively identifying knowledge gaps and risks, and work with the teams and team leaders to develop mitigation plans.
What are we looking for?
  • Degree in life sciences, with at least 5 years of relevant professional experience in the biopharmaceutical industry, including at least 2 years in relevant project/program management roles
  • Knowledge of and experience in biologic drug development, specifically CMC functions, including familiarity with drug substance and drug product development, manufacturing, and quality and regulatory requirements
  • Strong interpersonal skills with experience leading cross-functional teams in a matrix environment, and ability to work collaboratively with others across functions and levels
  • Proficiency with MS Word, Excel, Power Point, Project and SharePoint
  • Strong written and oral communication skills
How will you grow with us?

This position will allow you to join a growing and advancing company with an active pipeline.  As a part of a small, yet dynamic team, you will have the opportunity to quickly build ownership in your role and seek new opportunities for growth as we prepare to take products through the clinic to commercialization.  If you are looking to be a part of an innovative and fast-paced environment, join our team!

 

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.