Associate Director, CMC Analytics (Gene Therapy)

RhyGaze, AG; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Job summary

RhyGaze, a Philadelphia-area biotech, seeks an Associate Director/Director of Analytical Development to oversee outsourced analytical activities for gene therapy programs, ensuring GMP compliance and timely deliverables.

The role requires deep expertise in method qualification/validation, transfer, and lifecycle management for modalities such as AAV, DNA, RNA, and LNPs, with 10+ years in gene therapy product development, and experience authoring regulatory sections (IND/IMPD/BLAs/MAAs).

Qualifications

• Advanced degree in analytical science required; gene therapy experience preferred.
• Minimum 10 years direct hands-on experience in gene therapy product development.
• Experience managing outsourced analytical activities through CDMOs and external laboratories.
• Experience authoring regulatory sections (INDs, IMPDs, BLAs, MAAs) is required.

Responsibilities

• Lead external analytical development within the CMC organization for gene therapy programs.
• Manage analytical activities at CDMOs and external labs to ensure timelines, quality, and scientific standards.
• Provide scientific oversight for method development, qualification, validation, transfer, and troubleshooting.
• Support analytical strategies for drug substance and drug product from early clinical stages through late-phase development.
• Create and approve analytical certificates and analyses for sponsor-owned materials.
• Author, review and approve analytical protocols, reports, specifications, and stability data from external partners.
• Drive analytical readiness for regulatory submissions including IND, IMPD, BLA, and MAA filings.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, and external partners to align CMC objectives.
• Support investigations, deviations, OOS/OOT assessments, and change controls.
• Participate in CDMO/provider selection, onboarding, and governance.

Skills

Analytical method qualification

Analytical method validation

Method transfer

CDMO management

Regulatory documentation (IND/IMPD/BLA

AAV/DNA/RNA/LNP knowledge

Cross-functional collaboration

Communication skills

Education

MS/PhD in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field

Job description

RhyGaze, a Philadelphia-area biotech, seeks an Associate Director/Director of Analytical Development to oversee outsourced analytical activities for gene therapy programs, ensuring GMP compliance and timely deliverables.

The role requires deep expertise in method qualification/validation, transfer, and lifecycle management for modalities such as AAV, DNA, RNA, and LNPs, with 10+ years in gene therapy product development, and experience authoring regulatory sections (IND/IMPD/BLAs/MAAs).