Organisation

Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

We are currently 1200+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and the North East and global offices in the US, Australia, New Zealand, Japan, Hong Kong, South Africa, Singapore and Athens. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

Role

The Global Technical Lead is accountable for providing patient focused Technical leadership and delivery of technical projects for current Clinigen Commercial Products: Foscavir, Cardioxane, Totect, Savene, Ethyol, Imukin and Proleukin and any future commercial products.

Working closely with our Lamda business, as well as external companies, to ensure synergies and expertise for Clinigen are maximized.

Location for the role is flexible as the successful applicant could be based at any of our three UK sites: Weybridge, Burton-On-Trent or Newcastle Upon Tyne although flexibility to travel is essential

Responsibilities

  • Lead a Technical function providing the right level of proactivity and service to support the Technical Transfer of assets from the divesting organisations and related contract service providers and ongoing management of the Group’s pharmaceutical assets
  • Build and manage long-term, mutually respectful relationships with carefully selected contract manufacturing organisations (CMOs) to ensure robust, flexible and efficient supply chains
  • Clinical study planning, assignment and overseeing
  • CMO audit and compliance and due diligence
  • CTD dossier compilation, submission to the authorities and registration procedure
  • Build and lead cross functional team utilising Lamda resource as appropriate of relevant subject matter experts from the Technical Affairs team, capable of managing multiple technically challenging projects in parallel
  • Maintain up-to-date knowledge with trends and developments in the industry/market operating environment from a technical perspective and translate into benefits for Clinigen business
  • Work with Clinigen’s Business Development teams in the assessment of the technical aspects of potential new asset acquisitions, highlighting risk and mitigation and opportunities
  • Undertake technical due diligence reviews of potential new asset acquisitions as required

Requirements

  • Experience and proven technical abilities with direct manufacturing expertise in a wide range of dosage forms (liquid, cream, steriles, antibiotics, devices and biopharm)
  • Knowledge of modern analytical techniques
  • Awareness of regulatory processes
  • Commercial and business awareness
  • Excellent planning and organizational skills
  • Ability to communicate at all levels
  • Ability to motivate self and others

Application

If this role is of interest to you, please email a recent copy of your CV and a covering letter to recruitment@clinigengroup.com and a member of the Talent Acquisition team will be in touch.