Job description:
 

Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.

Oxford Biomedica’s Translational Sciences Group is responsible for supporting and optimising the development of internal and external therapeutic products through preclinical and clinical research, utilising high quality bioanalytical assays to provide a detailed understanding of safety and efficacy parameters

We are currently recruiting for a Director to join the team.  The purpose of this role is to lead, direct and manage the effective performance of a team of scientists undertaking analytical work (GxP and Research) and to oversee the timely delivery of projects for both internal and commercial partners.  Also, acts as Test Facility Management (the person who has the authority and formal responsibility for the organisation and functioning of the test facility according to the principles of OECD-Good Laboratory Practice)

Your responsibilities in this role would be:

• Accountable for the day-to-day operational performance of TSG’s analytical capability, with tactical focus on continuous improvement of the Department’s portfolio of varied GxP analytical offering.
• Support the development of a portfolio of gene therapy products through pre-clinical and clinical testing by providing a suite of “regulatory required” and/or “value-adding” analytics performed using cutting-edge assays and equipment.
• Manage and direct analytical work. Review, interpret and present data and produce reports suitable for Regulatory filings, publications or for business development activities.
• Identify and engage with external experts or academic groups to deliver collaborative projects that will advance product development goals.
• Identify future analytical requirements for new products to ensure efficient progress through the required developmental stages and to maximise the value of the product.
• Maintain awareness of external technologies and the GxP Regulatory landscape and advise and respond accordingly in order to ensure that OXB remain at the forefront of the analysis of the safety and efficacy of gene therapy products.
• Initiate and manage focussed research that will benefit aspects of the product development pipeline e.g. development of new biomarkers which would facilitate the early assessment of product safety or efficacy.
• Management of project work including the generation of work packages, establishing project timelines, efficient resourcing and clear communication with both internal and external clients.
• Proactively identify risks and issues to the relevant internal stakeholders and external collaborators at an early stage.

To be successful in this role, you will have the following skills and experience:

PhD or equivalent degree in a relevant Science (e.g. Biological sciences, Immunology, Virology, Medical Science, Molecular/Cellular biology)

Extensive experience in the Biotech/Pharma sector with a focus on analytical testing on ATMPs

Extensive knowledge and practical experience of five or more of the following areas: GxP / Regulatory documentation, gene therapy/ATMPs, viral vectors, cell biology, Biopharmaceutical industry, analytical techniques, high through-put technologies.

A deep understanding of Quality systems, Regulatory requirements and GxP compliance.

From a deep scientific understanding of diverse gene therapy products, will be able to identify analytical requirements which will meet Regulatory requirements and ideally, add value to the product.

Capable of disseminating key advances within related scientific fields that affect current R&D activities.

Extensive understanding of the R&D activities across internal departments and an ability to build working relationships across teams.

A strong track record in gene therapy and analytics (Industrial experience and/or strong publication record).

Proactively seek continuous Quality and analytical improvements (i.e. identify gaps & recommend improvements).

Interpret new Regulatory guidance and ensure timely delivery of appropriate, compliant and industry-leading analytical tests.

Provide insight and recommendations regarding how external technologies may be applied in novel or more efficient ways to add value to internal or external client products.

Conceive novel strategies and drive areas of research accordingly towards generation of patents and/or company trade secrets, or to navigate restrictive patent landscape.

Nurture a culture of creativity, collaboration and innovation within the Department

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

No agencies please

We offer:

We are committed to offering highly competitive reward packages for all our staff. That’s why, every year, we benchmark our salaries and benefits against the local pharmaceutical market – by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.

We’re looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It’s no mean feat, and we have to work together to make this happen.

Along the way, you’ll have a rich variety of opportunities to really develop your career. We’ll also give you a generous set of employee benefits and a competitive salary.