Director, Gene Therapy CMC Analytics

RhyGaze AG

Philadelphia (Philadelphia County)

On-site

Confidential

Full time

14 days+

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Job summary

RhyGaze AG seeks an experienced Associate Director/Director of Analytical Development to lead outsourced analytical activities across early-stage gene therapy programs. You will oversee CDMOs and external labs, ensure GMP-compliant method qualification, transfer, and validation, and drive readiness for IND/IMPD and BLA submissions.

The role requires deep expertise in AAV, DNA, RNA, and LNP modalities, with strong collaboration across Manufacturing, Quality, and Regulatory, in a fast-paced

Qualifications

Advanced degree in analytical-related field (MS/PhD preferred).
10+ years in gene therapy analytical development.
Experience managing CDMOs and external labs.
Experience authoring regulatory submissions (INDs/BLAs/IMPDs).

Responsibilities

Lead external analytical development within CMC for gene therapy programs.
Oversee CDMOs and external labs to meet timelines and quality.
Provide oversight for method development, qualification, validation, transfer, and troubleshooting.
Support analytical strategies for drug substance/product from early to late stages.
Prepare certificates, analysis reports, and stability data with external partners.
Author/review analytical protocols, reports, specs, validation packages.

Skills

Analytical method validation

Regulatory compliance

Stakeholder management

Analytical chemistry

GMP knowledge

Communication

Education

M.S. or Ph.D. preferred

Job description

The role requires deep expertise in AAV, DNA, RNA, and LNP modalities, with strong collaboration across Manufacturing, Quality, and Regulatory, in a fast-paced

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