(Associate) Director, CMC Analytical Development

RhyGaze AG; Pennsylvania; On-site; Confidential; Full time

Benefits offered by this job

Breakthrough therapies

Ophthalmology focus

Collaborative culture

Global team exposure

Job summary

RhyGaze seeks an Associate Director/Director of Analytical Development to lead externally sourced analytics for gene therapy programs, covering AAV, DNA, RNA, and LNP modalities.

In this fast-paced biotech environment, you will oversee CDMOs, drive method development/validation, and ensure GMP and regulatory readiness across IND/IMPD/BLA submissions.

Qualifications

• Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, or related field (MS/PhD preferred).
• 10+ years of hands-on gene therapy product development experience.
• Experience managing outsourced analytical activities through CDMOs.
• Experience supporting drug product development across clinical stages.
• Direct experience authoring regulatory sections (INDs, IMPDs, BLAs).

Responsibilities

• Lead external analytical development within the CMC organization for gene therapy programs.
• Oversee analytical activities at CDMOs and external labs, ensuring timelines, quality, and standards.
• Provide oversight for method development, qualification, validation, transfer, and troubleshooting.
• Support analytical strategies for drug substance and drug product from early to late clinical stages.
• Create and approve analytical documentation for sponsor materials and starting materials.
• Author/review analytical protocols, reports, specifications, and stability data from external partners.
• Drive readiness for regulatory submissions including IND, IMPD, BLA, and MAA.
• Collaborate with Manufacturing, Quality, and Regulatory Affairs to align CMC objectives.
• Support analytical investigations, deviations, OOS/OOT, and change controls.
• Contribute to supplier selection, onboarding, governance, and performance.
• Ensure outsourced activities comply with GMP and regulatory expectations.
• Act as internal analytical SME for AAV, DNA, RNA, and LNP modalities.

Skills

Analytical method qualification

Method validation

CDMO management

Gene therapy knowledge

Regulatory submissions (IND/BLAs)

Education

MS/PhD or equivalent

Job description

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 cross‑functional partner internally and externally. The successful candidate will thrive in a fast‑paced 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.

We are seeking candidates located in the Philadelphia region, as well as candidates who are willing to travel to and work in Philadelphia for one week each month.

Candidates needs legally able to work in the US (US citizen or US work permit).