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Gmp technical writer

Banbury
Oxford BioMedica (UK) Limited
Technical writer
Posted: 8 June
Offer description

Join Us in Changing Lives


Apply fast, check the full description by scrolling below to find out the full requirements for this role.

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 aGMP Technical Writer to join our Manufacturing team. In this role, you willauthor GMP related documentation including Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs), playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

* Writing clear and concise GMP documentation such as BMRs and SOPs to support lentiviral vector manufacturing for clinical and commercial use
* Coordinating and prioritising document creation, updates and reviews with manufacturing teams and subject matter experts to meet project timelines
* Initiating and managing document updates based on change controls and manufacturing schedules across all suites
* Ensuring consistency across GMP documents, assessing the impact of changes and escalating issues to relevant experts
* Participating in project meetings and communicating document update progress to stakeholders across departments
* Acting as subject matter expert for GMP documentation in support of manufacturing activities and regulatory audits
* Identifying and driving improvements in GMP documentation in collaboration with manufacturing teams and experts
* Maintaining high ethical standards and delivering high quality work consistently

We are looking for:

* Experience of authoring clear and concise GMP documentation such as SOPs or BMRs.
* Strong knowledge of GMP and regulatory documentation requirements.
* Competent user of MS Office applications especially MS word.
* Attention to detail to ensure documentation is free of errors and a keen interest in scientific writing in a highly regulated field.
* Experience working with electronic document management systems and an understanding of document workflows.

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 30 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. xsngvjr Change lives.

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