Senior CMC Translation Consultant

We are currently looking for a Senior CMC Translation Consultant py to join a leading Cell and Gene Therapy Consultancy. As the Senior CMC Translation Consultant you will be responsible for consulting with a range of Biotechnology and Biotherapeutics businesses, offering strategic advice to bridge the gap between R&D, Clinical Manufacturing and Product Commercialisation.

Their main office is based in Bristol but this is a fully remote role with semi-regular trips to site for company meetings as well as travel to client sites as and when required.

This is the perfect opportunity for a Cell Therapy specialist with knowledge of CMC, MSAT and or Process Development as well as a desire to use their years of experience to support the development of range of Cell therapy products.

Your duties as the Senior CMC Translation Consultant py will be varied however the key duties and responsibilities are as follows:

1. You will take a lead role in our CMC Translating Consultancy projects and interface directly with client senior management teams. You will partner with clients to support them through the translation journey from the Clients defined start point to the defined end point.

2. You will use your knowledge of Cell Therapy drug discovery and development to support a range of clients with the development of their therapies. You will offer advice on best practise and study requirements for regulatory submissions and fundementally ensuring the successful registration of life saving Cell Therapies.

3. You will Consult in a range of areas but specifically around Business planning; Translational, Manufacturing and CMC strategy as well as Risk and Gap analysis.

4. You will also offer Technical advice around Process and Analytical Development as well as Technology Transfer and Due diligence and audits.

To be successful in your application to this exciting opportunity as the Senior CMC Translation Consultant we are looking to identify the following on your profile and past history:

1. Extensive experience in the Biopharmaceutical space, ideally with knowledge of Cell Therapy products, where you are a Subject Matter expert within the Bioprocessing and Manufacture of Biological products.

2. Proven industry experience in the commercialisation of products is desired.

3. Ability to speak directly with clients and ability to challenge as appropriate to ensure the best advice and support is given to clients.

Key Words: Biopharmaceutical | Bioprocessing | Biologics | Cell Therapy | Gene Therapy | Upstream Process Development | Downstream process Development | In Process Analytical | CMC | Manufacturing | Quality