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Senior Scientist I, Analytical Development and Validation

2 months ago

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

Job description:
 

We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. 

 

We are currently recruiting for a Senior Scientist to join the Analytical Development and Technologies group.  The purpose of this role is to perform and manage analytical projects (CMC) encompassing assay development, qualification, validation, and QC implementation and to support other members of the team as needed to help the delivery of team goals and client work packages. 

 

Your responsibilities in this role would be: 

 

Responsible for leading the development, transfer, qualification, and validation of assays for testing lentiviral vectors for various cell and gene therapy products at different stages of clinical development. Manage and/or execute the delivery of work packages to clients while keeping up to date communications with client in meetings, internal project managers and other departments, with supervision from Group Leads. Write and review technical documents such as study documentation, qualification/validation plans and reports, SOPs etc. Act as an SME (Subject Matter Expert) in at least one type of assay from cell-based, qPCR/ddPCR, ELISA or HPLC: scientific and technical expertise, assist on troubleshooting and as a representative in cases of assay investigations (i.e. deviations from procedure, change controls, etc.) and discussions with client teams. Ensure robust technical transfer of methods to QC (Quality Control) and other departments/sites. Aspire to innovate within the team and company by bringing new ideas and concepts in all aspects of assay lifecycle for viral vectors. Support and mentor other scientists within the department. 

 

We are looking for: 

 

BSc, MSc or PhD in a Biosciences field or similar. Relevant laboratory experience in two or more of the following assay types: tissue culture, cell-based assays, qPCR/ddPCR, molecular biology, ELISA or HPLC. Experience in managing and delivering scientific/technical projects to defined objectives and timelines. Experience in liaising and communicating with different stakeholders, including external partners, clients or collaborators is an advantage. Experience in working or being exposed to a regulated GxP environment is an advantage. Knowledge/experience in virology and/or gene therapy products is an advantage.  Understanding of basic statistics in experimental data analysis and/or AQbD/DOE. Competency in data capture, documenting and reporting scientific/technical studies. Ability to work accurately in a busy and demanding environment, and to manage competing priorities. Credible and confident communicator (written & verbal) at all levels. Self-motivated with the ability to work proactively using own initiative. Demonstrates ability to work well in a team as well as independently. High level of familiarity with Microsoft Office. 

 

 

About Us: 

 

Oxford Biomedica is a quality and innovation-led viral vector CDMO 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; the driving force behind the majority of gene therapies.

 

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. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise

 

 

What’s in it for you: 

 

Highly competitive total reward packages  Wellbeing programmes  Development opportunities  Welcoming, friendly, supportive colleagues  A diverse and inclusive working environment  Our values are: Deliver Innovation, Be Inspiring and Have Integrity  State of the art laboratory and manufacturing facilities 

 

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

 

Collaborate. Contribute. Change lives

 


We offer:

 

 

 

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. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

 

 

 

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. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.