Based in the North West of England, the company has grown rapidly from a contract manufacturing company with a £1million turnover and 8 people 10 years ago to a contract manufacturing and contract development company with a turnover of £30million and 200 people today. Rapid growth continues and the company is now developing its own IP, so very exciting times.
We seek a fundamental and in depth knowledge and understanding of:
- CMC development, GLP and the development processes of generic pharmaceutical products gained within a generics company or larger contract house. Candidates straight out of big pharma, or early stage pharma conducting discovery formulation type work, are likely to struggle.
- EU (and ideally US) product submissions; including initial filing but also experience in dealing with questions from regulatory agencies.
- Analytical techniques; HPLC, ms/ms, GC; particle size. Expertise in method development and validation, according to ICH.
- QBD, QA/QC, compliance & regulatory requirements, H&S.
- Project management across multiple disciplines including analytical assay development, manufacturing, regulatory, clinical. Must be able to put together realistic project plans in terms of time and budget and deliver to that plan.
- Commercial management – able to contribute to portfolio building; awareness of critical factors in product selection for generic portfolio including market size, competition, ease of product delivery, etc.
In addition, experience of key dosage forms will be essential and in order of preference:
- Aerosols – MDI/respiratory is a key part of the business;. Must be familiar with key guidelines for inhaled device development especially requirements for generic products.
- Solid dose.
We need a problem solver rather than just problem finder. We do not need a “Rolls-Royce” mentality but a pragmatic approach as equipment and resources available are likely to be adequate for the job rather than over-provided. In a small, fast growing company must be willing to have a hands-on attitude and approach and be prepared to do practical work rather than run a desk. As the team grows the managerial aspects will become an increasing part of the role but initially this is likely to be less than 50% of time.
A comprehensive briefing document is available which describes the company and the opportunity.
To register your interest in this position, please contact David Wallder.