Analytical Development Manager/responsable Du Developpement Analytique

**MONTPELLIER - CDI**:
**Entreprise**:
It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.

Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.
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Sensorion est une société de biotechnologie pionnière au stade clinique dédiée au développement de thérapies innovantes pour restaurer, traiter et prévenir les troubles de l’audition, un important besoin médical non-satisfait.

Sensorion développe dans le cadre de la mise en place d’une large collaboration stratégique ciblant la génétique de l’audition avec l’Institut Pasteur, deux programmes de thérapie génique visant à corriger les formes monogéniques héréditaires de surdité. SENS-501 (OTOF-GT) vise la surdité causée par des mutations du gène codant pour l’otoferline et est actuellement développé dans le cadre d’une étude clinique de phase 1/2, et GJB2-GT cible la perte auditive liée à des mutations du gène GJB2, afin de potentiellement traiter d’importants segments de perte auditive chez les adultes et les enfants. La société travaille également sur l’identification de biomarqueurs afin d’améliorer le diagnostic de ces maladies peu ou mal soignées.

Le portefeuille de Sensorion comprend également des programmes de petite molécule au stade clinique pour le traitement et la prévention des troubles de l’audition. Son portefeuille de produits en phase clinique comprend un produit de Phase 2 : le SENS-401 (Arazasetron) qui progresse dans une étude clinique de Preuve de Concept dans l’ototoxicité induite par le cisplatine (CIO), et dans une étude en partenariat avec Cochlear Limited, chez des patients devant recevoir un implant cochléaire. Une étude de Phase 2 du SENS-401 dans la perte auditive neurosensorielle soudaine (SSNHL) a également été finalisée en janvier 2022.

**Poste**:
**Mission**

The Analytical Development Manager is a key role within the CMC Gene Therapy department at Sensorion, specialized in the development of analytical methods and production processes for Gene Therapy products. The Analytical Development Manager is responsible for the implementation and development of analytical methods for AAV vectors, under the supervision of the Head of Analytical Development & Quality Control, in compliance with quality procedures, health and safety rules, budget and timelines.

**Main Activities**
- Management of a team of Scientists, Technicians and/or Apprentices in Gene Therapy Analytical Development;
- Develop and qualify analytical methods of AAV vectors (specific-product and platform);
- Design, organize, execute and/or supervise experiments, manage data, lab-books, batch records;
- Review experimental data, provide feedback and direction for further study;
- Write study protocols and reports, present data internally and externally, where appropriate;
- Write and/or review SOPs;
- Manage projects to improve the efficiency and productivity of the department;
- Participate in the tech transfer and qualification/validation with external partners (CDMO/CRO), review GMP documentation and support review of third party deviations;
- Provide technical leadership for Analytical methods, and maintain current understanding of industry trends;
- Provide recommendations for evaluation of new technologies, where appropriate;
- Participate in the drafting of patents, publications, conferences;
- Participate in the general operation of the laboratory: purchasing, setup & installation of CMC GT laboratory equipment, within the quality assurance system.
- Advocate a strong health and safety culture rules, identify areas for improvement and implement recommended resolutions.
- Interact with teams in TechOps department, and with cross-functional teams across Sensorion;
- Lead troubleshooting activities/ investigations both internally and with third parties.

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**Missions**

Le Responsable du Développement Analytique est un poste clé au sein du département C