At a Glance
- Tasks: Write clear GMP documentation to support life-changing therapies.
- Company: Join OXB, a pioneer in cell and gene therapy.
- Benefits: Enjoy wellbeing programs, career development, and a supportive culture.
- Other info: Collaborative environment with state-of-the-art facilities and growth opportunities.
- Why this job: Make a real impact in advancing innovative therapies for patients.
- Qualifications: Experience in GMP documentation and strong attention to detail.
The predicted salary is between 35000 - 45000 £ per year.
At OXB, our people are at the heart of everything we do. We’re on a mission to enable life‑changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.
Role Overview
We’re currently recruiting for a GMP Technical Writer to join our Manufacturing team. 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.
Responsibilities
- 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
Requirements
- 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 OXB
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.
Benefits
- Wellbeing programs 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’re future‑focused and growing fast. We succeed together—through passion, commitment, and teamwork.
GMP Technical Writer employer: Oxford Biomedica
At OXB, we pride ourselves on being an exceptional employer, fostering a supportive and inclusive culture that prioritises employee wellbeing and career development. Our state-of-the-art facilities and commitment to our core values—Responsible, Responsive, Resilient, and Respectful—create an inspiring environment where passionate individuals can thrive and contribute to life-changing therapies for patients worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land GMP Technical Writer
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Oxford Biomedica. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Oxford Biomedica.
✨Leverage Internships for Full-time Roles
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Oxford Biomedica is looking for. A tailored application can really make you stand out!
We think you need these skills to ace GMP Technical Writer
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Oxford Biomedica!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Oxford Biomedica that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Oxford Biomedica!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Oxford Biomedica, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Oxford Biomedica
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Oxford Biomedica that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Oxford Biomedica’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
