Director, CMC Quality Control & Quality Assurance

HAYA Therapeutics • San Diego, CA

6d

About The Position

At HAYA Therapeutics, we are revolutionizing RNA-guided genome-targeting therapies to treat fibrosis, heart failure, and other serious diseases associated with aging. Our innovative platform leverages long non-coding RNAs (lncRNAs)—key regulators within the “dark matter” of the genome—to develop first-in-class, highly specific therapies that modulate gene expression and restore cellular function. Recognized for our innovation, HAYA received the prestigious Innosuisse Certificate for Sustainable Growth and has been nominated as TOP Innovative Companies in Switzerland 2025. As a fast-growing biotech, we offer an entrepreneurial, science-driven environment where you’ll have a direct impact on shaping our pipeline and advancing RNA medicine.

Requirements

• Advanced scientific knowledge in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutics, or a related scientific discipline, typically acquired through a Ph.D. or M.S. degree.
• Deep, hands-on technical understanding of oligonucleotide (ASO, siRNA) CMC architecture, including specialized knowledge of modified oligonucleotides, inherent impurities, and complex analytical troubleshooting.
• Extensive experience selecting, managing, and auditing Contract Development and Manufacturing Organizations (CDMOs) and contract testing laboratories.
• Comprehensive mastery of global GMP regulations, ICH guidelines, and direct experience authoring CMC modules for RNA-based therapeutics within regulatory submission frameworks.
• Proven capability to lead cross-functional quality strategies, manage technical teams, and scale global quality infrastructure in a high-growth biotech environment (leveling targeted to match depth of leadership maturity).
• An entrepreneurial and collaborative mindset that thrives under accountability and adapts swiftly within a fast-paced, innovative biotech ecosystem.
• Strategic vision and decision-making agility, showing the capability to bridge technical QC/QA data with global regulatory and corporate objectives.
• Exceptional problem-solving capabilities, with a natural inclination to dive deep into analytical complexities and discover proactive resolutions.
• Strong cross-functional communication skills, effectively translating complex quality metrics into actionable workflows for internal discovery and external development partners

Responsibilities

• Define and execute phase-appropriate Quality Control and Quality Assurance strategies for antisense oligonucleotide (ASO) programs across external manufacturing networks to ensure robust cGMP compliance and accelerate pipeline progression from discovery through clinical development.
• Define and execute phase-appropriate analytical and QC strategies for oligonucleotide drug substance (DS) and drug product (DP) to ensure robust clinical candidate evaluation.
• Establish and approve product specifications, retest periods, and stability protocols to safeguard product quality throughout the clinical lifecycle.
• Manage and govern external CDMO, CTL, and critical raw material supplier networks through qualification audits and routine oversight to ensure strict global cGMP compliance (FDA, EMA, ICH).
• Oversee and validate the transfer and qualification of analytical methods (including LC-MS, HPLC, and capillary electrophoresis) at external partners to guarantee technical accuracy and continuity.
• Direct and review master/executed batch records, deviations, out-of-specification (OOS) investigations, and corrective/preventive actions (CAPAs) to authorize timely clinical batch releases.
• Author and defend the Quality/CMC sections of regulatory filings (including INDs, IMPDs, and future NDAs/MAAs) to achieve successful global regulatory submissions.
• Partner with internal Discovery, Chemistry, and Clinical Operations teams to align CMC quality timelines with broader corporate milestones.
• Drive long-term strategic manufacturing partnerships and mentor expanding technical teams to actively scale HAYA's global quality management system (QMS).

What This Job Offers

• Job Type: Full-time
• Career Level: Director