Pioneering Medicines Executive Director, CMC (Chemistry, Manufacturing & Controls)

What if... We could harness the power of Flagships scientific platforms and create novel treatment options that benefit more patients sooner

Pioneering Medicines (PM) an initiative of Flagship Pioneering is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagships scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

Position Summary:

We are seeking an Executive Director CMC (Chemistry Manufacturing & Controls) with a proven track record of driving portfolio-level CMC strategy and execution across multiple emerging modality programs simultaneously. This is a senior leadership role operating at the intersection of science strategy and operationsrequiring the ability to set direction across a complex multimodality pipeline and build CMC function as a competitive advantage for Pioneering Medicines. 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. This leader will be equally comfortable shaping long-range CMC strategy at the portfolio level and resolving complex technical challenges at the program level. They will define how PM approaches emerging modalities build and leverage a best-in-class external Contract Development and Manufacturing Organizations (CDMO) network combined with the strategic acumen to make portfolio-level resourcing decisions. They will be a thought leader in innovative approaches and champion adoption of AI-enabled CMC tools.

Responsibilities:

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development Drug Delivery / Pre-formulation Analytical Development Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• 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
• Oversee the identification evaluation and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio
• Engage and align key stakeholders across Technical Operations Research Translational Medicine and Regulatory Affairs to establish CMC development paradigms resolve cross-functional trade-offs and ensure portfolio decisions reflect both scientific rigor and operational reality
• Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor as needed
• Serves as an ambassador of PM for external stakeholders and industry as a whole

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
• 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
• 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.
• Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously including developing and managing CMC budgets risk management and delivery against aggressive timelines
• Extensive experience identifying selecting contracting and managing CDMOs and CROs with specialized emerging modality capabilities including leading technology transfer and resolving technical challenges at external sites
• Thought leadership in innovation including novel delivery high-throughput process development and platform-based approaches to elevate program / portfolio value
• 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; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
• 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
• Entrepreneurial builder energized by creating structure in ambiguous fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
• Collaborative low-ego leadership style with genuine investment in team development and cross-functional relationships

About Flagship

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health sustainability and beyond.

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 islargely withoutprecedent. Our team of scientists entrepreneurial leaders and professional capital managersare eachaligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people andplanet.

Many of thecompaniesFlagship has founded have addressed humanitys most urgent challenges: 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 has been recognized twice on FORTUNEs Change the World list an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been named four times to Fast Companys annual list of the Worlds Most Innovative Companies.

At Flagship we recognize there is no perfect candidate. If you have some of the experience listed above but not all please apply anyway. Experience comes in many forms skills are transferable and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively FSP) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees isstrictly prohibitedunless contacted directly by Flagship Pioneerings internal Talent Acquisition team. Any resumesubmittedby an agency in the absence of a signed agreement will automatically become the property of FSP and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $228000 - $313500. Compensation for the role will depend on a number of factors including a candidates qualifications skills competencies and experience. 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 Mediciness good faith estimate as of the date of publication and may be modified in the future.

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