Biotech companies are often so-called virtual companies that work a lot with freelancers for consulting, as project managers or as the actual implementer for specialized topics. Small and medium-sized biotech companies often outsource all analytical and manufacturing processes. This makes it vital to have a CMO manager who completely understands the whole process, can speak to people eye-to-eye and knows when it is important to bring up a painful subject considering later quality and regulatory purposes.
Biotech is not Pharma
The main difference of a biotech product is that the manufacturing method is based on living organisms such as bacteria or mammalian cells. Unlike in pharma where a chemical synthesis is the basis. Logically, the requirements for a biotech project, especially when talking about GMP are very different. And special expertise such as fermentation or filtration is necessary to be able to conduct projects successfully.
Biomanufacturing is special: QPs in the biologic area sometimes need to have special qualifications: in Germany for example, it is necessary to provide information that one has worked in microbiology / serology for at least 3 years in a GMP production or the authority won’t accept you for batch releases. You cannot take it for granted that an agency knows these things.
K-Recruiting has this special know-how. Therefore we know exactly which questions to ask you, as a consultant first, to make sure that project acquisition is as efficient as possible for you.
Also in your Regulatory Affairs Department you should consider this. It can be helpful to get someone with biotech experience on board. Innovative biotech companies often focus on orphan drugs, against rare diseases. There are shortened regulatory procedures and regulations can differ from standard regulatory filings and should be known to your consultant.
Let’s take a look at the genercis industry. The most recent – and very promising – development is the progress of Biosimilars, meaning the “copy” of a biologic. Noting, that even a top 10 biotech company now develops biosimilars makes it clear that the biosimilar business is up and coming.
Biosimilars also are different from the long-established generics business, as the investment and research effort is considerably higher. Therefore you should make sure that in an area such as clinical development you will find a freelance MD who was already involved in this field. Because the study for a biosimilar, and this is special, has the purpose of proving similarity to the originator product. This has to be reflected in its design, not primarily safety of efficacy.
Synergies by recruiting throughout Europe
Just like in the US, there are a couple of biotech hubs in Europe, which are usually built because they promise more innovation and you hope for infrastructural synergies. A high density of biotech firms can be found in Switzerland, Denmark & Sweden, Germany, UK & Ireland and in Belgium & the Netherlands.
So it does make sense for biotech / biosimilar companies and Consultants equally to be working with a recruiting agency specializing on freelance recruiting for all of Europe!