Director of CMC

Title: Director of CMC

Reports to: CEO

Stage: Stealth Series A biotech

Location: South San Francisco, CA

Role Overview

We are a stealth Series A antibody therapeutics company seeking an execution-driven Director of Chemistry, Manufacturing, and Controls (CMC) to provide strategic and operational leadership for all CMC activities across the company’s development pipeline. This individual will be accountable for establishing and executing the CMC strategy from preclinical through clinical readiness, ensuring that all programs are developed in a scientifically sound, regulatory-compliant, and capital-efficient manner.

This is a hands-on leadership role requiring deep technical expertise in biologics development, strong external partnership management, and the ability to build scalable CMC infrastructure in a fast-paced biotech environment.

Key Responsibilities

CMC Strategy & Leadership

·      Define and execute global CMC strategy aligned with corporate, clinical, and regulatory objectives.

·      Serve as the primary CMC representative to the executive team.

·      Establish phase-appropriate CMC governance, decision frameworks, and risk management processes.

Process Development & Drug Substance (DS) Manufacturing

·      Lead cell line development and development of upstream and downstream processes.

·      Oversee CDMOs and ensure robust, scalable, and reproducible manufacturing processes.

·      Drive process characterization, control strategy development, and lifecycle management.

·      Ensure readiness for scale-up, clinical manufacturing, and commercialization.

Analytical & Product Characterization

·      Oversee development and qualification of analytical methods supporting release, stability, and comparability.

·      Ensure comprehensive product characterization and impurity control strategies.

·      Guide comparability strategies across process changes and site transfers.

Formulation & Drug Product (DP)

·      Lead formulation and drug product development, including container closure systems and fill-finish strategy.

·      Ensure drug product robustness through clinical stages.

·      Manage label/pack of clinical supplies.

Regulatory & Quality Interface

·      Own CMC sections of regulatory submissions (IND, CTA, etc.).

·      Partner closely with Quality and Regulatory Affairs to define CMC regulatory strategy globally.

·      Ensure CMC activities comply with GMP, ICH, and regional regulatory requirements.

·      Support health authority interactions related to CMC topics.

External Partner Management

·      Manage CDMOs, CROs, and key vendors.

·      Establish clear deliverables, KPIs, and governance with external partners.

·      Serve as person-in-plant during GMP manufacturing

·      Ensure high-quality execution, timelines, and budget adherence.

Budget Management

·      Develop and manage CMC budgets and long-range operating plans.

·      Optimize resource allocation to balance speed, quality, and cost.

Required Qualifications

·      10 years of progressive experience in biologics CMC, with increasing leadership responsibility.

·      Proven experience advancing biologics from preclinical into clinical development and/or commercialization.

·      Demonstrated ownership of CMC sections of regulatory filings (IND/CTA/BLA/MAA).

·      Deep knowledge of biologics process development, formulation, analytical development, and GMP manufacturing.

·      Strong understanding of regulatory CMC expectations across development stages.

·      Experience with CDMO oversight and tech transfer.

·      Familiarity with comparability, control strategies, and lifecycle management.

·      Experience operating in early-stage, resource-constrained environments.

·      Strong cross-functional collaboration with Research, Clinical, Regulatory, and Quality.

·      Excellent communication skills with internal and external stakeholders.

·      High ownership mindset; comfortable being accountable for outcomes.

Preferred Qualifications

·      Experience with multi-specific antibodies.

·      Experience in venture-backed or high-growth biotech environments, including prior experience working directly with a CEO or founder.

·      Advanced degree (M.S., Ph.D., M.D.) in a scientific discipline.

·      Prior interaction with FDA/EMA on CMC matters.

The estimated base salary range for this position is $215,000 - $265,000. Actual pay will be based on several factors including experience and qualifications.