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Director, CMC Portfolio Management & Operations

External
Beeline Medicines logoBeeline Medicines · Boston, MA
Full-timeOn-site2w ago
ForecastingLeadershipProcess Improvement
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Requirements

  • Education: Bachelor's degree required; advanced degree (M.S., Ph.D., or MBA) in a life sciences, or engineering discipline strongly preferred
  • 10+ years of experience in pharmaceutical or biopharmaceutical program/project management, portfolio operations, or CMC operations, with at least
  • 3 years in a cross-functional leadership or senior individual contributor role within matrix CMC organization.
  • Deep understanding of the drug development process, with specific familiarity with CMC development activities across small molecules and/or biologics from IND through NDA/BLA.
  • Experience building and managing integrated CMC development timelines, resource models, and cross-program risk registers in a multi-asset biotech or pharma setting.
  • Proven ability to desi

Additional Information

About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Director, CMC Portfolio Management & Operations is a critical enterprise-level role serving as the operational backbone of the Chief Technical Operations Officer's organization. This individual is responsible for establishing and running the CMC program management framework, driving cross-functional operational cadence, and ensuring that the company's CMC portfolio is planned, tracked, and delivered with rigor and transparency. Sitting at the intersection of science, strategy, and operations, this leader brings structured program management discipline to a fast-moving, pre-commercial biotech environment - enabling the CMC leadership team to make high-quality decisions efficiently, allocate resources strategically, and keep pipeline programs on track. This role does not manage a deep scientific function but rather elevates the effectiveness of the entire CMC organization through operational excellence, portfolio visibility, and organizational rhythm. Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday . Additional on-site days may be required based on business needs, team priorities, or leadership direction. Essential Duties and Responsibilities: Design and own the CMC portfolio management framework, including integrated development timelines, cross-program milestone tracking, risk registers, and stage-gate decision processes across all active programs. Serve as the primary program management partner to the Chief Technical Operations Officer, preparing executive-level portfolio reviews, board materials, and CMC readout packages for senior leadership. Establish and lead the operational cadence of the CMC organization - including leadership team meetings, cross-functional program reviews, quarterly planning cycles, and annual operating plan development. Own the CMC resource planning and capacity management process, working with CMC functional leaders to model headcount needs, CDMO bandwidth, and external partner capacity against portfolio demands. Build and maintain a centralized CMC portfolio dashboard, ensuring real-time visibility into program status, key milestones, risks, issues, and dependencies across the pipeline. Lead CMC-wide process improvement initiatives, identifying operational bottlenecks, standardizing project management practices, and implementing tools and systems that scale with organizational growth. Partner with Finance to develop and track the annual CMC budget, provide variance reporting, and ensure accurate forecasting of program spend across internal and external activities. Coordinate cross-functional CMC interfaces with Clinical Development, Regulatory Affairs, Quality, Supply Chain, and Program Management to ensure seamless information flow and aligned deliverable timelines. Manage and continuously improve CMC knowledge management systems, ensuring critical documents, decision logs, SOPs, and program records are organized, accessible, and current. Support Business Development, partnership, and due diligence activities from an operational perspective, including the preparation of CMC data rooms, CMC capability summaries, and program timeline materials for external audiences. Perform other duties and responsibilities as assigned


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