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Executive Director, CMC (Chemistry, Manufacturing & Controls) at Flagship Pioneering | Cambridge, MA

Flagship Pioneering, Inc.Cambridge, MA USANew
On-site Full-time $228K/yr - $313.5K/yr

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Experience Level

Senior Level Manager

Qualifications

Ideal candidates should have: A PhD in a relevant scientific discipline or equivalent experience. 10+ years of experience in CMC with significant leadership roles in biopharmaceuticals or related fields. Demonstrated success in managing complex CMC projects and teams in a fast-paced environment. Strong interpersonal and communication skills, with the ability to influence stakeholders at all levels. A proven ability to build effective relationships with external partners, including CDMOs. Innovative thinking and a passion for utilizing cutting-edge technologies in CMC processes.

About the job

Flagship Pioneering’s Pioneering Medicines (PM) initiative focuses on creating new therapies for serious diseases by integrating multiple scientific platforms. The team aims to address significant unmet medical needs through advanced biopharmaceutical R&D.

Role overview

The Executive Director, CMC (Chemistry, Manufacturing & Controls) will provide both strategic and operational leadership across the full PM portfolio, spanning research through late-stage clinical development. This position reports to the SVP, CMC & Technical Operations and plays a central role in shaping CMC as a core strength for Pioneering Medicines.

This leader will develop long-term CMC strategies, resolve technical challenges at both the portfolio and program levels, and define approaches for emerging modalities. Building and managing a top-tier network of external Contract Development and Manufacturing Organizations (CDMOs) is a key part of the role. The Executive Director will also guide resource allocation and promote adoption of innovative, including AI-enabled, CMC tools.

Key responsibilities

  • Serve as a senior member of the Technical Operations leadership team, overseeing CMC areas such as Drug Substance Development, Drug Delivery/Pre-formulation, Analytical Development, Product Development, and Regulatory CMC. Responsible for CMC strategy and portfolio deliverables.
  • Grow and guide the CMC organization by recruiting, developing, and retaining talent. Foster a culture focused on excellence, accountability, and ongoing improvement.
  • Lead end-to-end CMC processes for a diverse and expanding portfolio of multimodality compounds. Ensure timely advancement of programs and proactively identify and manage portfolio-level CMC risks.

What sets this role apart

This position sits at the intersection of science, strategy, and operations. The Executive Director will influence how Pioneering Medicines approaches new therapeutic modalities and will be recognized as a thought leader in the field, especially in adopting innovative methodologies and digital tools.

About Flagship Pioneering, Inc.

Flagship Pioneering is a leading investment firm dedicated to creating and growing groundbreaking life sciences companies. Our Pioneering Medicines initiative is focused on advancing innovative biopharmaceuticals that address significant healthcare challenges through transformative science and technology.

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