Director, External Analytical Development for Gene Therapy

RhyGaze AG; Basel; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Impactful work in biotech

Collaborative culture

Global project exposure

Zusammenfassung

RhyGaze AG in Basel, Switzerland, is seeking an experienced Associate Director/Director of Analytical Development to lead outsourced analytical activities within the CMC organization for gene therapy programs.

You will oversee CDMOs and external labs, drive method qualification, transfer, and lifecycle management, and support regulatory submissions while collaborating with Manufacturing, Quality, and Regulatory teams to ensure GMP compliance in a fast-paced biotech setting.

Qualifikationen

• Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field (MS/PhD preferred).
• 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 regulatory documents (INDs, IMPDs, BLAs).

Aufgaben

• 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

Kenntnisse

Analytical method qualification

Method validation

CDMO management

Regulatory submissions support

GMP experience

Ausbildung

MS/PhD in relevant field

Jobbeschreibung

RhyGaze AG in Basel, Switzerland, is seeking an experienced Associate Director/Director of Analytical Development to lead outsourced analytical activities within the CMC organization for gene therapy programs.

You will oversee CDMOs and external labs, drive method qualification, transfer, and lifecycle management, and support regulatory submissions while collaborating with Manufacturing, Quality, and Regulatory teams to ensure GMP compliance in a fast-paced biotech setting.