Associate Director/Director, CMC Operations and Portfolio Management

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 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.

Key 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).

Operational Excellence & Infrastructure

• Design and implement scalable CMC project management tools, processes, and best‑practice strategies.
• Build and maintain risk registers, scenario planning frameworks, and program dashboards.
• Evaluate and optimise 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.

Cross‑Functional Leadership

• 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.

External Partner & Supply Oversight

• 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.

Requirements

• BS/MS (PhD optional) in Life Sciences, Engineering, Biochemistry, or related field.
• ~8+ years (Associate Director) 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.

Preferred

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

Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Associate Director level we target $200,000 to $240,000. The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally.