At a Glance
- Tasks: Write clear GMP documentation and collaborate with teams to support life-changing therapies.
- Company: Join OXB, a pioneer in viral vector development with a mission to change lives.
- Benefits: Enjoy competitive rewards, wellbeing programmes, and career development opportunities.
- Other info: Be part of a collaborative culture in state-of-the-art facilities.
- Why this job: Make a real impact in a supportive and innovative environment focused on health.
- Qualifications: Experience in GMP documentation and strong attention to detail required.
The predicted salary is between 35000 - 45000 £ per year.
At OXB, our people are at the heart of everything we do. We are on a mission to enable life-changing therapies to reach patients around the world and we are looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.
In this role, you will author 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.
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 world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB'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.
Why Join Us?
- Competitive total reward packages
- Wellbeing programmes that support your mental and physical health
- Career development opportunities to 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, we are future-focused and growing fast. We succeed together through passion, commitment, and teamwork.
Ready to Make a Difference? Collaborate. Contribute. Change lives.
GMP Technical Writer in Oxford employer: Oxford BioMedica Limited
At OXB, we pride ourselves on being a leading employer in the biopharmaceutical sector, where our commitment to innovation and quality is matched by our dedication to employee wellbeing and growth. Our GMP Technical Writer role offers a unique opportunity to contribute to life-changing therapies while working in a supportive and inclusive environment that fosters collaboration and professional development. With state-of-the-art facilities and a culture that embodies our core values of being Responsible, Responsive, Resilient, and Respectful, OXB is the ideal place for passionate individuals looking to make a meaningful impact.
StudySmarter Expert Advice🤫
We think this is how you could land GMP Technical Writer in Oxford
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching OXB and understanding their mission. Be ready to discuss how your skills in GMP documentation can contribute to their goals. Show them you're not just another candidate!
✨Tip Number 3
Practice your communication skills! As a GMP Technical Writer, clarity is key. Mock interviews with friends can help you articulate your experience and demonstrate your attention to detail.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of the OXB team.
We think you need these skills to ace GMP Technical Writer in Oxford
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience with GMP documentation. We want to see how your skills align with our mission and values, so don’t hold back on showcasing your relevant expertise!
Showcase Your Attention to Detail:Since this role involves writing clear and concise documentation, it’s crucial to demonstrate your attention to detail. Proofread your application thoroughly to ensure it’s free of errors – we appreciate high-quality work!
Highlight Your Collaboration Skills:As a GMP Technical Writer, you’ll be coordinating with various teams. Use your application to illustrate your ability to work collaboratively and communicate effectively with different stakeholders. We love team players!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Oxford BioMedica Limited
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and regulatory documentation requirements. Be prepared to discuss specific examples of how you've authored SOPs or BMRs in the past, as this will show your expertise and understanding of the role.
✨Showcase Your Attention to Detail
During the interview, highlight your attention to detail by discussing how you ensure documentation is free of errors. You might want to share a story about a time when your meticulousness made a significant difference in a project, especially in a highly regulated environment.
✨Familiarise Yourself with Document Management Systems
Since experience with electronic document management systems is crucial for this role, be ready to talk about any systems you've used before. If you can, mention how you’ve navigated document workflows and how you’ve contributed to improving these processes in previous positions.
✨Emphasise Collaboration Skills
As a GMP Technical Writer, you'll need to coordinate with various teams. Prepare to discuss how you've successfully collaborated with manufacturing teams and subject matter experts in the past. Share examples of how you communicated document updates and managed timelines effectively.
