Employment opportunities

Vacancies

  • Head of CMC
  • Supply chain and CDMO manager
  • Head of Regulatory and QA

Background

Following positive clinical trial results in a Phase II study in hospitalised COVID-19 patients, Synairgen is conducting a global Phase III trial with results expected 2021. Trials are also being performed in at-risk COVID-19 patients in the home setting. The drug, SNG001, interferon beta-1a nebuliser solution, is an inhaled broad-spectrum antiviral which has been shown to have clinical benefit in previous Phase II trials in patients with lung diseases with respiratory viral infections. Interferon beta is a naturally occurring protein which orchestrates the body’s antiviral defences and has been shown to have antiviral activity against a broad range of respiratory viruses including the virus that causes COVID-19.

SNG001, interferon beta-1a nebuliser solution, is currently presented in glass syringes (PFS). Commercial manufacturing of SNG001 in PFS is being performed by Catalent. We are also evaluating the use of blow-filled seal technology (BFS) at Catalent.  To meet the demands if clinical studies are successful, we are working with a second drug substance supplier. Drug substance from this manufacturer will be used in commercial manufacture. The intention is to be able to supply the market in the middle of next year.

We are looking to bring expertise into the company to lead and manage this activity. We are currently supported by some very able consultants.

 

Attributes

  • Biologics experience
  • Experience in bringing new products to global markets
  • Experienced in identifying and managing CDMOs
  • A self-starter that thrives in a rewarding but challenging environment. We are trying to get a drug that could save lives to the market as soon as possible.
  • A team player with a positive can-do attitude
  • Needs to be able to work full time and at times show flexibility with hours to allow communication with international CDMOs. We have manufacturing in other countries requiring calls outside UK standard working hours
  • Experience of working in a small/medium-sized company
  • Can involve remote working
  • Available now

 

The roles

 

  • Head of CMC
    • Take responsibility for coordinating commercial and clinical manufacturing, global launch, clinical and commercial supply and distribution including relevant authorisations
    • Oversee writing of and approval of global CMC regulatory dossiers (CTAs, INDs, MAAs, BLAs)
    • Line manage roles below and build team as appropriate

 

  • Supply chain and CDMO manager
    • Lead and project manage the day-to-day interaction with CDMOs responsible for active substance and drug product manufacturing and supply including DS manufacturing supply, DP manufacturing supply, production schedules, release and stability testing, packaging and labelling, serialisation and distribution
    • Work with internal and external quality assurance units to ensure that the product supply is compliant
    • Have international shipping and customs experience

 

  • Head of Regulatory and QA
    • Work with CDMO on RCA / CAPA dev etc.
    • Develop and establish the QMS to support commercial manufacture and supply identifying and remediating existing gaps in the system to meet global regulatory requirements
    • Understand the regulatory framework in the EU, US and ROW for manufacturing and commercial launch
    • Implement and oversee the commercial supply chain from a regulatory perspective
    • Support production of global CMC regulatory dossiers
    • Work with external regulatory consultants to coordinate agency interactions and submissions
    • Work with external manufacturing consultants to ensure that the product complies with global regulatory requirements

 

If you are interested in applying for any of the above positions, please send your CV and covering letter to HR@synairgen.com to apply.