Flagshippioneeringinc

Flagshippioneeringinc

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

Cambridge, MA USA · Director

Sponsorship not specified$228k-$330kDetected 7 days ago
Machine LearningComplianceRecruitingFDA RegulatoryResearchLeadershipGxPRegulatory Affairs

About the role

  • We are seeking an Executive Director or Vice President, CMC (Chemistry, Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously.
  • This position reports to the SVP, CMC & Technical Operations.
  • This role will serve as the strategic and operational owner of CMC across the full PM portfolio from research interface through early and late clinical development.

Responsibilities

  • Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC.
  • Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team
  • Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy
  • Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships
  • Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs
  • Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value.
  • Responsible for building and scaling the CMC organization and defining its strategic direction. Recruit, develop, and retain a high-performing CMC team; invest in talent and cultivate a culture of excellence, accountability, and continuous improvement
  • Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation
  • Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations.
  • This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs

Requirements

  • PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered)
  • Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
  • Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities
  • Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
  • Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
  • Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders
  • Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
  • high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
  • What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent.
  • If you have some of the experience listed above but not all, please apply anyway.

Nice to have

  • Deep hands-on expertise in small molecules and biologics.
  • Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies

Skills

  • They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Compensation

  • Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits.

Benefits

  • vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.
  • We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.
  • and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.
  • Pioneering Medicines currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits.
  • Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.

Company info

  • At Flagship, we recognize there is no perfect candidate.

Visa & Work Authorization

  • California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information.
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