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Pioneering Medicines: Executive Director / Vice Predident, CMC (Chemistry, Manufacturing & Controls)

1 hour, 19 minutes ago
United States
Full-time
Executive
Operations Manager
Operations
Apply Now
Flagship Pioneering

Flagship Pioneering

Flagship Pioneering is a biotechnology firm that invents and develops innovative life science platforms and companies aimed at transforming human health and promoting sustainability.

Biotechnology
251-1K
Founded 1999
View All Jobs 10

Description

  • Serve as a key member of the Technical Operations leadership team and lead CMC functions including drug substance development, drug delivery/pre-formulation, analytical development, product development, and regulatory CMC.
  • Build, scale, and define the strategic direction of the CMC organization, including recruiting, developing, and retaining a high-performing team.
  • Own end-to-end CMC execution across a growing portfolio of multimodality compounds and ensure programs advance on time and on strategy.
  • Identify, prioritize, and mitigate portfolio-level CMC risks across multiple simultaneous programs.
  • Build and manage a high-performing external CDMO network, including partner selection, assessment, relationship management, and capacity planning.
  • Identify, evaluate, and implement novel technologies and innovations to improve portfolio value, speed, and efficiency.
  • Leverage AI-driven development, manufacturing, and advanced analytics approaches to accelerate CMC timelines.
  • Align stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to resolve trade-offs and support portfolio decisions.
  • Oversee CMC handoffs and establish fit-for-purpose development and manufacturing pathways for novel modalities.
  • Serve as a CMC strategic advisor and external ambassador for Pioneering Medicines.

Requirements

  • PhD in a relevant scientific discipline with 15+ years of progressive CMC experience, or MS with 18+ years, or BS with 20+ years considered.
  • Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs.
  • Deep hands-on expertise in small molecules and biologics.
  • Preferred experience in advanced modalities such as nucleic acids, cell therapies, or gene therapies.
  • Demonstrated track record of filing and defending regulatory dossiers such as INDs, CTAs, BLAs/NDAs, or MAAs across multiple programs and modalities.
  • Current working knowledge of global regulatory expectations, including FDA, EMA, and PMDA, with direct experience in agency interactions on CMC topics.
  • Proven ability to own CMC strategy and execution across a multi-program portfolio, including budget management, risk management, and delivery against aggressive timelines.
  • Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs, including technology transfer and external-site troubleshooting.
  • Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches.
  • Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms.
  • Executive presence with the ability to influence cross-functional leaders and communicate complex CMC strategy to non-specialist audiences.
  • Experience partnering with GxP Quality to establish SOPs, change control, and deviation management in a development-stage environment.
  • Entrepreneurial, collaborative leadership style with a bias for action and comfort making decisions with incomplete information.

Benefits

  • Salary range of $228,000 to $330,000.
  • Annual incentive program.
  • Healthcare coverage.
  • Retirement benefits.
  • Broad range of additional benefits.

Interested in this position?

Apply directly on the company website

Apply Now

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