Closing Date: 02 Jan 17
Salary (£): Competitive
We are recruiting this role on behalf of our Client - an Oxford based clinical stage biotechnology company. My Client is a leader in the research and development of T cell-based therapies for the treatment of cancer. The business is rapidly growing in both the UK and USA and they have multiple early-phase clinical trials ongoing in oncology centres across both the US and Europe.
Based just outside Oxford, UK, the company offers the opportunity to take part in pioneering the commercial development of T cell therapy. The company has an inventive and collaborative culture, where employees are valued and inspired as well as rewarded for their ideas and contributions. The organisation of research has created an environment where it is possible to make both individual and team contributions towards scientific excellence.
The role is to lead the upstream and downstream lentiviral vector process development and optimization activities in the Vector Development Group. The purpose of this role is to create a central point of contact to provide bioprocess leadership to the vector development team. The role is a collaborative one, working closely with the upstream and downstream technical leads internally and also to act as a technical interface to our CMOs and development partners. Furthermore the role will be expected to contribute to the strategic direction and planning of the bioprocessing aspect of vector development.
Leadership of the of the bioprocess development function within the vector development team – 20%
In collaboration with the upstream and downstream technical leads, provide technical review of experimental designs, results, conclusions and the process development plans of the bioprocess development function within Vector Development – 25%
In conjunction with the Head of Vector Development and Head of Process Development provide the strategic direction for vector bioprocessing to drive increased process optimisation, process understanding and decreased COGS – 20%
Lead the tech transfer of new and updated processes to our CMOs, collaborating with the upstream and downstream technical leads to ensure success – 15%
Manage any outsourced development activities for vector bioprocessing with subcontractors, collaborating with the upstream and downstream technical leads as appropriate – 20%
BSc or higher qualification in relevant area (preferably biological, biochemical engineering disciplines). Experience with bioprocess development in the gene therapy, vaccine and/or biopharmaceutical fields, with at least 10 years relevant industrial experience is required.
The role requires a depth of experience in the process development, optimization, scale-up and technology transfer of bioprocesses. The role would lead the vector bioprocess development effort within Vector Development group and would be responsible for the development of the entire bioprocess including the upstream production of the vector and downstream purification and concentration unit operations. Therefore a deep understanding of technologies suitable for scale-up of bioprocesses including bioreactors (suspension or adherent based cell culture), chromatography and dead-end / tangential flow filtration is required. Significant knowledge and experience of the scale-up and scale-down of upstream and downstream unit operations is also key to the success of the role.
The role will also be responsible for the tech transfer of new or updated processes to our CMOs. Therefore the role requires an in-depth understanding of tech transfer and GMP translation to include the technical review of documentation such as process descriptions, sampling plans and batch records. Experience of in-plant presence during tech transfer would also be required.
Experience in live virus or gene therapy product formulation would be an advantage.
Knowledge of viral vector biology and molecular biology would be an advantage but is not essential.
Experience of assisting in the authoring of regulatory submissions (IND/IMPD) would also be a significant advantage.
Experience of BLA/MAA preparation including process understanding, risk assessment and control strategy implementation with any category of biopharmaceutical (recombinant protein, vaccine or an ATMP) would also be an advantage.
The relevant skills and competencies to provide line management of a process development team (4 – 8 scientists) are necessary. These skills include the ability to, motivate, delegate, and provide personal development insight for direct and indirect reports. Furthermore the ability to simultaneously improve both efficiency and quality within the team are required through driving efficient team work is required.
A key requirement is the ability to work collaboratively both within the team and externally. The role requires cross-functional working to ensure success; with input from molecular biologists, cell biologists, cell culture scientists, bioreactor specialists and chromatography/filtration experts. A collaborative approach will be required for success.
The role requires an excellent communicator who is able to provide clear messages, both internally and to external partners.
Skills and knowledge relating to the development, scale-up and tech transfer of bioprocesses destined for GMP manufacture are key for this role. These skills should include the ability to critically examine in-process data, evaluating both yield and product quality leading to a risk based approach to further optimise and understand the bioprocess. An attention to detail is also key to enable thorough review of development reports, tech transfer documents and batch records.
The responsibility of the role is to provide the leadership of the vector bioprocess function within the Vector Development group. The job holder will also work with the Heads of Vector Development and Process Development to define the strategic direction of the bioprocess development.
Please call Marc Joseph on 01753 216664 for further discussion, or send your CV to email@example.com.
Key Words Vector Bioprocess development, team leader, line management, scientific, bioengineering, cell culture, oncology, t -cell therapy, ELISA, chromotography, process development, biopharmaceuticals
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SL1 4AA, UK
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