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Director - Quality & Manufacturing Development

4 months ago

Oxford Oxfordshire, United Kingdom Oxford BioMedica (UK) Limited Full time

We are currently recruiting for a Director, Manufacturing Sciences and Technology (MSAT). The purpose of this role is to lead, direct and manage the effective performance of a team of MSAT scientists and engineers to deliver technical projects and tasks within OXB, working directly with stakeholders, clients, and third-party Contract Manufacturing Organisations (CMO’s) to ensure delivery is on time and to the required quality.
MSAT enable the introduction of new manufacturing facilities, technology, equipment, and processes to Oxford Biomedica. We contribute to the delivery of customer projects, and to the future growth of the company.
Accountable for delivery of multiple technical projects/tasks working directly with customers and third party CMOs to ensure project timelines are met according to internal and/or customer needs.
Proactively identifies and communicates project risk and issues to senior management, relevant internal stakeholders, and external collaborators.
Provides technical oversight relating to all OXB’s manufacturing sites and third party CMO activities.
Ensures compliance with OXB’s Quality, Safety and Environmental systems and procedures.
Provides scientific expertise and/or process engineering support as and when necessary, for OXB processes and facilities, including facility design, process scale up and new equipment introduction.
Maintains awareness of external technology and patent landscape in order to ensure OXB remains at the forefront of the industry.
Develop external client relationships within Pharma/Biotech industry.

Degree or equivalent experience in a relevant Science (e.g. biological sciences, Biochemical Engineering) with substantial relevant experience in an industrial setting
Significant experience of GMP manufacturing and knowledge of OXB processes including quality and regulatory requirements
Strong background in supporting regulatory submissions.
Significant industrial experience in the scale-up and industrialisation of GMP manufacturing bioprocesses, technical support & process troubleshooting.
Recognised SME in technical field of expertise covering areas such as technology transfer, USP and DSP development, optimisation and scale-up, single-use disposable systems, aseptic fill/finish, process validation and GMP manufacturing operations.
Knowledge of quality management systems, environmental, health and safety aspects of the work and regulatory requirements
Oxford Biomedica is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus, and adenoviral vectors. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
Highly competitive total reward packages
Wellbeing programmes
Development opportunities
Deliver Innovation, Be Inspiring and Have Integrity
State of the art laboratory and manufacturing facilities
Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).
Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.
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