Director, CMC Portfolio Management & Operations

Beeline Medicines•Boston, MA

6d•Hybrid

About The Position

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.

Requirements

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 design and implement operational infrastructure in a pre-commercial or rapidly scaling organization, including meeting cadences, reporting frameworks, and decision-support systems.
Experience supporting budget development, financial tracking, and variance analysis for a technical R&D function in collaboration with Finance.
Familiarity with CDMO governance, external partner management, and the operational interfaces between internal CMC teams and contract organizations.
Demonstrated ability to lead through influence in a matrixed organization, aligning senior scientific and operational stakeholders around shared priorities without direct line authority over all constituents.
Strong written and verbal communication skills, with a track record of producing high-quality portfolio reviews, operating plan documents, and cross-functional alignment materials.
Skilled facilitator with experience leading executive-level meetings, planning sessions, and cross-functional working groups with clarity, structure, and appropriate follow-through.
Collaborative communication style with the ability to build trust and credibility quickly across scientific, operational, regulatory, financial, and business development stakeholders in a matrixed organization.

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