(Associate) Director, CMC Analytical Development

Rhy Gaze 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.

Overview 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 oversee outsourced analytical activities performed by external Contract Development and Manufacturing Organizations (CDMOs) and analytical partners across early‑stage development programs.

Responsibilities 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 of 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.

Act as the internal analytical SME for modalities including AAV, DNA, RNA, and LNPs.

Requirements Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field (MS/Ph D preferred).

At least 10 years of direct, hands‑on experience with gene therapy product development.

Experience managing outsourced analytical activities through CDMOs and external laboratories.

Experience supporting drug product development across early and late clinical phases.

Direct experience authoring relevant sections of regulatory documents, including briefing packages, INDs, IMPDs and BLAs.

Knowledge & Skills Strong expertise in analytical method qualification and validation within regulated GMP environments.

Deep understanding of analytical requirements for gene therapy/gene editing products, including one or more of the following: AAV, DNA, RNA, or LNP.

Hands‑on scientific mindset with strong attention to detail.

Committed, proactive, and accountable.

Strong communication and stakeholder‑management skills.

Ability to operate effectively in a fast‑paced and evolving biotech environment.

Benefits Opportunity to help develop breakthrough therapies for patients with serious vision‑threatening diseases.

Work alongside a passionate, highly experienced team at the forefront of ophthalmology innovation.

Meaningful impact in a growing biotech company.

Collaborative, entrepreneurial culture where science and innovation drive decision‑making.

The position is based in Basel, Switzerland.

Candidates are expected to be on site three days per week.

As part of an international team, the working language is English; hence, strong written and spoken English skills are essential.

Candidate must hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. #J-18808-Ljbffr