Associate Director/Director, CMC Operations and Portfolio Management

Merida Biosciences•Cambridge, MA

4h•$200,000 - $240,000

About The Position

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking an Associate Director/Director, CMC Operations & Portfolio Management to drive operational excellence and portfolio-level execution across our biologics development programs. This role supports both CMC program execution and the growth of the organization. Working closely with CMC Technical Leads, the focus is on strong planning, proactive risk management, and clear cross-functional coordination. The position combines hands-on program support with broader efforts to build the systems, processes, and visibility needed to scale the CMC function. This is initially an individual contributor role with the opportunity to build and oversee a small team over time, including project management and drug supply operations.

Requirements

BS/MS (PhD optional) in Life Sciences, Engineering, Biochemistry, or related field
~8+ years (AD) or ~10–12+ years (Director) of experience in biotech/pharma, including:
Direct experience in biologics CMC development
Experience in CMC project/program management
Strong understanding of the end-to-end CMC lifecycle, from early development through clinical stages and regulatory submission
Experience supporting global regulatory filings (IND, CTA, BLA/MAA)
Experience working with CDMOs and external manufacturing partners
Exposure to or experience with drug supply planning and operations
Ability to clearly delineate and operate within a Tech Lead (strategy) / PM (execution & risk) model
Strong program management skills, including planning, risk management, and cross-functional coordination
Demonstrated ability to build or improve operational processes, tools, and team effectiveness
Excellent communication and stakeholder management skills, with the ability to influence without authority
Comfort operating in a fast-paced, early-stage biotech environment

Nice To Haves

Experience in a startup or emerging biotech company
Experience building or scaling CMC PM or operations functions
Familiarity with portfolio-level planning and governance

Responsibilities

Partner with CMC Technical Leads to support execution across biologics programs, ensuring alignment with development strategy and corporate timelines
Co-own integrated CMC plans with Technical Leads, including timelines, milestones, and cross-functional dependencies
Drive risk identification, mitigation planning, and communication across programs
Establish and maintain portfolio-level dashboards, KPIs, and reporting for senior leadership and governance forums
Support clear and effective communication of CMC progress, risks, and key decisions to Asset Development Teams (ADTs)
Design and implement scalable CMC project management tools, processes, and best practices
Build and maintain risk registers, scenario planning frameworks, and program dashboards
Evaluate and optimize meeting structures, governance, and communication cadence across the CMC organization
Drive continuous improvement initiatives to enhance execution, transparency, and efficiency
Ensure clear roles and responsibilities for critical CMC workstreams to support efficient and timely execution
Partner closely with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and Global Program Management
Ensure alignment of CMC activities with clinical and regulatory timelines (IND, CTA, BLA/MAA readiness)
Facilitate cross-functional meetings and ensure clear tracking of decisions, actions, and priorities
Support CDMO strategy, selection, timelines, and budget alignment at the program level
Provide high-level coordination across external partners to ensure alignment on development and manufacturing plans