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

Requirements

Education & Experience

• Advanced degree in Analytical Chemistry Biochemistry Biotechnology Molecular Biology Pharmaceutical Sciences or related field (MS/PhD preferred).
• At least 10 years of direct hands-on experience with gene therapy product development is required.
• 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 is required.

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

Why Join Us

• 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 3 days per week onsite. As part of an international team the working language is English; hence strong written and spoken English skills are essential.

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland.