Director : Process Development (Biologics) : Interim / Permanent

Our Client is a very well established international pharmaceutical company, headquartered in continental Europe. Its extensive and impressive product portfolio (commercialised and in development) encompasses a range of therapeutic areas and includes small molecules and biologics.

The company’s ambitious plans for the future call for an increased focus on biologics and include the creation within the UK of a “Biotechnology Centre” which will become a centre of excellence for the development (and manufacture of clinical supplies) of an increasing number of assets which will have been licensed in from a number of global partners.

The intention is that the manufacture of product required for Phases II and III studies, and for subsequent commercialisation, will be outsourced.

Work to establish this Biotechnology Centre is well underway, with an office up and running in Reading, recruitment of some initial key personnel now complete, with more to follow.

One of the most important of these newly-created positions is that of Director of Process Development (Biologics) – a role that will involve reviewing the current capabilities within our Client relating to antibody upstream process development and the creation of robust upstream technical transfer packages.

As the number of products increases for which the Biotechnology Centre will be responsible, this key position will ultimately need to be filled by a full-time permanent employee, but in the short-term and until such time as the ideal candidate has been identified, an experienced Interim Manager will be appointed, probably for an initial period of 6-12 months, 2-3 days / week. The ideal scenario would be for the Interim Manager to ultimately transition into a position of employment with the company.

Candidates are likely to be educated to PhD level and have significant experience in the successful upstream development of mammalian cell culture-derived antibody processes including DoE & Quality by Design approaches. They will have managed relevant teams in this area and have successfully transferred antibody processes between sites and companies.

The role will involve some international travel (e.g. to the company’s European HQ.)

This is a genuinely exciting opportunity in an ambitious company.

The successful candidate will not be inheriting a well-established role in an existing structure, but will instead be making a significant and highly-visible contribution to the creation of something new and of long-term strategic importance to the company.

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