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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

What if... we could leverage Flagship’s groundbreaking scientific platforms to develop innovative treatment options that reach more patients, sooner?

Pioneering Medicines (PM), a flagship initiative of Flagship Pioneering, is establishing a world-class biopharmaceutical R&D capability dedicated to creating transformative treatments for patients by utilizing Flagship's unique scientific platforms. Our distinctive approach allows us to integrate various platforms, resulting in genuinely novel therapies for serious diseases with significant unmet medical needs.

Position Summary:

We are on the lookout for an Executive Director, CMC (Chemistry, Manufacturing & Controls) who possesses a strong history of driving portfolio-level CMC strategies and executing across multiple emerging modality programs simultaneously. This senior leadership role sits at the nexus of science, strategy, and operations, requiring the ability to navigate a complex multimodality pipeline and establish CMC functions as a competitive asset for Pioneering Medicines. Reporting directly to the SVP, CMC & Technical Operations, this position is pivotal.

This leader will be responsible for the strategic and operational oversight of CMC across the entire PM portfolio, from research interface through early and late clinical development. They will excel in developing long-term CMC strategies at the portfolio level while adeptly resolving intricate technical challenges at the program level. They will define PM's approach to emerging modalities, build and utilize a premier external Contract Development and Manufacturing Organizations (CDMO) network, and possess the strategic insight to make portfolio-level resource decisions. Additionally, they will be regarded as a thought leader in innovative methodologies and will champion the adoption of AI-enabled CMC tools.

Key Responsibilities:

  • Act as a vital member of the Technical Operations leadership team, overseeing CMC functions such as Drug Substance Development, Drug Delivery/Pre-formulation, Analytical Development, Product Development, and Regulatory CMC. You will hold accountability for all aspects of CMC functional strategy and portfolio deliverables.
  • Drive the growth and strategic direction of the CMC organization. This includes recruiting, developing, and retaining a high-performing CMC team while fostering a culture of excellence, accountability, and continuous improvement.
  • Lead and ensure the execution of end-to-end CMC processes across a growing portfolio of multimodality compounds, ensuring timely and strategic program advancement. You will be responsible for identifying portfolio-level CMC risks.

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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