StellenbeschreibungpRhyGaze 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. /p pWe 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. /p pThe 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 crossfunctional partner internally and externally. The successful candidate will thrive in a fastpaced biotech environment and demonstrate a collaborative, committed, and pragmatic /p pmindset. /p h2Tasks /h2 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 and 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 h2Requirements /h2 pstrongEducation Experience /strong /p 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 is required. /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, is required. /li /ul pstrongKnowledge Skills /strong /p 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 h2Benefits /h2 pstrongWhy Join Us /strong /p 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. Candidates are expected to be 3 days per week onsite. As part of an international team, the working language is English; hence, strong written and spoken English skills are essential. /p pCandidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. /pbrpRhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness. Our lead program targets patients with blinding retinal diseases, and we are committed to bringing life-changing treatments to those in need. /p
