Director, Analytical Development/QC (Biologics)
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About The Position
Mirador Therapeutics, Inc. is seeking a strategic and technical leader to build and lead the biologics and small molecule analytical development and quality control (QC) function in support of its innovative and fast-growing pipeline of novel therapies. The ideal candidate will apply state-of-the-art analytical method development, product characterization, and quality control for biologics, including antibody-drug conjugates (ADCs), and small molecules across various drug development phases. This role requires demonstrated analytical and QC experience across regulatory regions, establishing accepted product control strategies from pre-clinical stages to commercialization. The Director will oversee the analytical development and QC function, ensuring the development of robust phase-appropriate analytical methods for the characterization and release of intermediates, active pharmaceutical ingredients, and drug product candidates. This position involves building a high-performing analytical/QC function within the Chemistry, Manufacturing, and Controls (CMC) department to support clinical development and commercialization of both large and small molecule programs. The Director will also assist in selecting contract development and manufacturing organizations (CDMOs) and contract laboratories for non-GMP/GMP development and manufacturing. Collaboration with cross-functional teams, including Quality Assurance (QA) and Regulatory Affairs, is essential to ensure alignment of analytical methods and controls with overall project goals. The Director will execute the overall analytical development control strategy throughout the development process, utilizing robust analytical and biological methods for characterizing starting materials, intermediates, products, and known/potential impurities. The role also includes guiding the development of critical quality attributes, specifications, and control strategies, ensuring phase-appropriate method qualification and testing activities for biologic and small molecule products at qualified vendors. In addition, the Director will manage investigational testing and assist with deviations, investigations, and corrective and preventive actions (CAPAs) related to both internal and external quality management systems. The position requires expertise in developing and validating both biologic and small molecule analytical methods for early and late-stage products in development, overseeing all analytical activities at CDMOs, and providing guidance to ensure compliance with regulatory requirements. The Director will also be responsible for developing team members to improve their technical capabilities and communicating product quality risks at all stages of development. This role demands the ability to complete projects within established timelines, resource constraints, and regulatory requirements, while also working closely with regulatory CMC to ensure that analytical methods and specifications meet all regulatory guidelines and are accurately represented in regulatory filings.
