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 800+ 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.
The role is responsible for the accountability for the coordination and delivery of technical projects, predominantly in support of the Specialty Pharmaceuticals and Clinical Trial Supply (CTS) Divisions. The role requires the proven ability to work across internal functions and to operate effectively with Contract Manufacturing Organizations (CMOs).
The Key responsibilities for this role are:
- Responsible for the coordination, scoping and costing of Technology Transfer activities for API and finished products.
- Responsible for the planning and execution of technical projects for the SP and CTS divisions using a set of agreed “project tools”. Including preparation of project plans and hands on participation in the practical delivery of the plan and project deliverables.
- To be responsible for the technical ownership / stewardship of SP manufactured API and finished products processes (manufacturing, quality control and packaging) with respect to the planning, review and approval (via change control) and implementation of changes in conjunction with CMOs. To be the point of contact for technical investigations (deviations) and remediation (CAPAs).
- To work cross functionally within Clinigen Group companies (predominantly SP and CTS) to identify, evaluate and manage continuous improvement projects (process enhancements which provide a measurable improvement in Quality or productivity).
- To be involved in due diligence processes as required and as lead by the New Products Acquisition team by providing Technical input. To support the integration of new product acquisitions into the Quality, Regulatory and Technical systems and processes.
- To be responsible for the technical evaluation of stability data and manufacturing processes using statistical process control / process capability techniques, so as to ensure data and processes are in control.
- Responsible for ensuring the Quality, Regulatory and Technical departments are aware of all current and future changes to European and ROW technical and quality legislation. To lead assessments of the impact and actions necessary to ensure that the Clinigen Group companies would be compliant with any draft legislation.
The successful candidate will have the following:
- Extensive experience and proven technical abilities with direct manufacturing expertise in a wide range of dosage forms (aseptically products, freeze dried products and solid dose products).
- 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.
- Proactive, inquisitive and detailed.
- Strong team player.
- Customer Focused.
- Solutions orientated.
- Educated to degree level with a Life Science degree or equivalent.
- Previous experience in a pharmaceutical manufacturing or technical support role (+ 3 years).
- Experience of working with CMOs (+3 years).
- Collaborative attitude is essential.
- Willingness to travel outside of UK.
If this role is of interest to you please send a recent copy of your CV
to email@example.com and a member of the Talent Acquisition team will be in touch.