Manufacturing Equipment & Systems Specialist

Company description:

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 patients 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.

Job description:

Join Us in Changing Lives

AtOXB, our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful.

Were currently recruiting for aManufacturing Equipment & Systems Specialistto join ourManufacturing Team. In this role, you willensure compliance of GMP Equipment & Systems within the manufacturing department enabling efficient batch delivery against production schedule in line with GMP, safety and environmental requirements, playing a key part in advancing our mission and making a real difference.

Please note that this role is an onsite opportunity.

Your responsibilities in this role would be:

• Generating and reviewing of periodic Asset documentation including audit trails, Asset Folders, and User Access levels
• Maintaining access control for manufacturing and ensuring trained personnel and host access to support Validation / Engineering activities
• Supporting in progressing of Validation Lifecycle documents and activities for assets (URS, DQ, RQ, VRRs, CST etc)
• Generating and updating of asset documentation e.g. equipment logbooks, SOPs
• Providing technical support and point of contact for queries / data from internal departments e.g. Validation and support QMS, and Audits and Client requests
• Liaising with Equipment & Systems vendors to resolve any technical issues that are identified
• Executing NPI actions which relate to equipment introduction or modification
• Supporting the implementation and review of HAZOPs
• Acting as the subject matter expert where required for QMS and supporting/taking ownership of QMS records for equipment and Systems

We are Looking For:

• A-Level, preferably science based with previous industrial experience
• Graduate in STEM subject (preferred)
• Experience working in a GMP environment
• Experience working with of Cell & Gene therapy manufacturing equipment and systems. e.g. bioreactors, chromatography, clean rooms etc.
• Ability to travel across all Oxfordshire sites
• Willingness to working within Cleanroom environment when required

About Us:

OXB 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.

OXB collaborates with some of the worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXBs 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.

Why Join Us?

• Competitive total reward packages
• Wellbeing programmesthat support your mental and physical health
• Career development opportunitiesto help you grow and thrive
• Supportive, inclusive, and collaborative culture
• State-of-the-art labs and manufacturing facilities
• A company that lives its values:Responsible, Responsive, Resilient, Respect

We want you to feel inspired every day. At OXB, were future-focused and growing fast. We succeed togetherthrough passion, commitment, and teamwork.

Ready to Make a Difference?

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 patients 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.

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