Director, CMC Quality Control & Quality Assurance

1. Purpose: 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. Accountabilities 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). 3. Required Knowledge and Experience Academic Foundations: Advanced scientific knowledge in Chemistry, Biochemistry, Analytical Chemistry, Pharmaceutics, or a related scientific discipline, typically acquired through a Ph.D. or M.S. degree. Oligonucleotide Technical Expertise: Deep, hands-on technical understanding of oligonucleotide (ASO, siRNA) CMC architecture, including specialized knowledge of modified oligonucleotides, inherent impurities, and complex analytical troubleshooting. External Operations & Vendor Management: Extensive experience selecting, managing, and auditing Contract Development and Manufacturing Organizations (CDMOs) and contract testing laboratories. Regulatory & Quality Systems Savvy: Comprehensive mastery of global GMP regulations, ICH guidelines, and direct experience authoring CMC modules for RNA-based therapeutics within regulatory submission frameworks. Leadership Track Record: 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). 4. Leadership Profile The successful candidate will demonstrate: 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. HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development. At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics. #J-18808-Ljbffr