(Associate) Director, CMC Analytical Development

Das ist der Job

ppRhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness.

Darum lohnt es sich

This role will oversee outsourced analytical activities performed by external Contract Development and Manufacturing Organizations (CDMOs) and analytical partners across early‑stage development programs. /p h3Responsibilities /h3 ul liLead and oversee external analytical development within the CMC organization for gene therapy programs. /li liManage analytical activities performed at CDMOs and external testing laboratories, ensuring timelines, quality, and scientific standards are achieved. /li liProvide scientific oversight for analytical method development, qualification, validation, transfer, and troubleshooting activities. /li liSupport analytical strategies for drug substance and drug product development from early clinical stages through late‑phase development. /li liCreate and approve Certificate of Analysis for sponsor‑owned Drug Substance, Drug Product, and Starting Materials. /li liAuthor, review and approve analytical protocols, reports, specifications, method validation packages, and stability data generated by external partners. /li liDrive analytical readiness for regulatory submissions including IND, IMPD, BLA, and MAA filings. /li liCollaborate closely with Manufacturing, Quality, Regulatory Affairs, and external partners to ensure alignment of CMC objectives. /li liSupport analytical investigations, deviations, OOS/OOT assessments, comparability studies, and change controls. /li liContribute to selection, onboarding, governance, and performance management of CDMOs and analytical service providers. /li liEnsure all outsourced analytical activities comply with GMP and applicable regulatory expectations. /li liAct as the internal analytical SME for modalities including AAV, DNA, RNA, and LNPs. /li /ul h3Requirements /h3 ul liAdvanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field (MS/PhD preferred). /li liAt least 10 years of direct, hands‑on experience with gene therapy product development. /li liExperience managing outsourced analytical activities through CDMOs and external laboratories. /li liExperience supporting drug product development across early and late clinical phases. /li liDirect experience authoring relevant sections of regulatory documents, including briefing packages, INDs, IMPDs and BLAs. /li /ul h3Knowledge Skills /h3 ul liStrong expertise in analytical method qualification and validation within regulated GMP environments. /li liDeep understanding of analytical requirements for gene therapy/gene editing products, including one or more of the following: AAV, DNA, RNA, or LNP. /li liHands‑on scientific mindset with strong attention to detail. /li liCommitted, proactive, and accountable. /li liStrong communication and stakeholder‑management skills. /li liAbility to operate effectively in a fast‑paced and evolving biotech environment. /li /ul h3Benefits /h3 ul liOpportunity to help develop breakthrough therapies for patients with serious vision‑threatening diseases. /li liWork alongside a passionate, highly experienced team at the forefront of ophthalmology innovation. /li liMeaningful impact in a growing biotech company. /li liCollaborative, entrepreneurial culture where science and innovation drive decision‑making. /li /ul pThe position is based in Basel, Switzerland.

As part of an international team, the working language is English; hence, strong written and spoken English skills are essential. /p pCandidate must hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. /p /p #J-18808-Ljbffr Our programs target patients with blinding retinal diseases, and we are committed to bringing life‑changing treatments to those in need. /p h3Overview /h3 pWe are seeking an experienced and highly motivated Associate Director/Director of Analytical Development to join our Chemistry, Manufacturing and Controls (CMC) organization.

Candidates are expected to be on site three days per week.