Synairgen are hiring9 Nov 2021 13:32
Synairgen Research Limited is a drug discovery and development company specialising in respiratory diseases. Following positive clinical trial results in a Phase II study with the antiviral drug SNG001 (an inhaled formulation of recombinant Interferon beta) in hospitalised COVID-19 patients, Synairgen is currently conducting a global Phase III trial, which is set to readout in early 2022.
The key challenge for the CMC team will be the scale-up of manufacturing and supply of IFN-Beta including development of a global manufacturing network. A skilled and experienced individual with the required CMC knowledge is sought, with specific experience in late stage CMC regulatory submissions, comparability studies, technology transfer and rapid introduction of large scale manufacturing.
An opportunity has arisen within the company for a permanent, experienced Director of CMC, responsible for co-ordinating commercial and clinical manufacturing. Working alongside the existing Director of CMC, this newly created role will be leading the CMC activities for the company throughout the product lifecycle. The job function will report into the Senior Vice President of CMC and is home office based with a competitive package.
Key Skills and Experience required for the role
At least 15 years' experience in CMC and late stage product development
Proven knowledge of regulatory agency expectations for CMC late stage product registration
Experienced in transition from development to commercial manufacturing operations
Proven experience in performing as part of a team delivering regulatory product approval
Proven experience in managing Contract Manufacturing Organisations
Ability to define clear strategic and tactical goals while managing project teams
Effective communicator internally and externally of the organisation
Good team working skills and used to working flexibly in a small dynamic team
To apply, please send your current C.V. and a covering letter to hr@synairgen.com
https://www.linkedin.com/jobs/view/2787021336