(Associate) Director, CMC Analytical Development

RhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness. Our programs target patients with blinding retinal diseases, and we are committed to bringing life-changing treatments to those in need.

We are seeking an experienced and highly motivated Associate Director/Director of Analytical Development to join our Chemistry, Manufacturing and Controls (CMC) organization. This role will be responsible for overseeing outsourced analytical activities performed by external Contract Development and Manufacturing Organizations (CDMOs) and analytical partners across early-stage development programs.

The ideal candidate brings strong expertise in analytical method qualification, validation, transfer, and lifecycle management for gene therapy products, including gene editing-, adeno-associated virus (AAV)-, and/or lipid nanoparticle (LNP)-based modalities. This individual will serve as the analytical CMC lead across external networks, ensuring scientific rigor, operational excellence, and regulatory compliance while acting as a key crossfunctional partner internally and externally. The successful candidate will thrive in a fastpaced biotech environment and demonstrate a collaborative, committed, and pragmatic

mindset.

Tasks

• Lead and oversee external analytical development within the CMC organization for gene therapy programs.

• Manage analytical activities performed at CDMOs and external testing laboratories, ensuring timelines, quality, and scientific standards are achieved.

• Provide scientific oversight for analytical method development, qualification, validation, transfer, and troubleshooting activities.

• Support analytical strategies for drug substance and drug product development from early clinical stages through late-phase development.

• Create and approve Certificate and Analysis for sponsor owned Drug Substance, Drug Product, and Starting Materials.

• Author, review and approve analytical protocols, reports, specifications, method validation packages, and stability data generated by external partners.

• Drive analytical readiness for regulatory submissions including IND, IMPD, BLA, and MAA filings.

• Collaborate closely with Manufacturing, Quality, Regulatory Affairs, and external partners to ensure alignment of CMC objectives.

• Support analytical investigations, deviations, OOS/OOT assessments, comparability studies, and change controls.

• Contribute to selection, onboarding, governance, and performance management of CDMOs and analytical service providers.

• Ensure all outsourced analytical activities comply with GMP and applicable regulatory expectations.