Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).
Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates.
The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin.
The Company is uniquely placed through its platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet medical need.
The Process Development Manager – Bioprocesses F/M will join the CMC Gene Therapy Department at Sensorion, specialized in the development of analytical methods and production processes of Gene Therapy products.
The Process Development Manager – Bioprocesses F/M will play a key role in the implementation and establishment of cell-based process for AAV production in suspension by transient transfection, under the supervision of the Head of CMC Gene Therapy, in compliance with quality procedures, health and safety rules, budget and deadlines.
The Process Development Manager – Bioprocesses F/M is a permanent position based in Montpellier.
- Team management of Technicians Process Development ;
- Development and implementation of appropriate USP and DSP processes for AAV vector;
- Design, organize, execute or supervise experiments, manage data, lab-books, batch records;
- Write study protocols and reports, present data internally;
- Write or supervise SOP;
- Manage projects to improve the efficiency and productivity of the department;
- Participate in the tech transfer from R&D to GMP environment, review GMP documentation;
- Participate in the drafting of patents, publications, conferences;
- Participate in the general operation of the laboratory: purchasing, management, setup & installation of CMC GT laboratory, health & safety, in the quality assurance system.
- Educational background in biology biotechnology, biochemical engineering or related (MSc or PhD);
- A minimum of 6 years of industrial experience (from R&D to GMP environment);
- A prior successful team management experience;
- Practical experience with cell culture in bioreactor, viral purification by chromatography on AKTA platform system;
- Rigorous, autonomous, motivated, organization skills;
- Ability to work within a team and project group;
- Notion of GLP and QA system;
- Good written and spoken in French and English.
Position to be filled as soon as possible