At a Glance
- Tasks: Lead a dynamic Biosafety team, ensuring compliance and excellence in pathogen safety.
- Company: Join a leading plasma-derived products business with global influence.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Collaborative environment with opportunities for international travel and knowledge sharing.
- Why this job: Shape the future of biosafety and protect patients through innovative practices.
- Qualifications: Degree in Virology, Biochemistry, or Biology; senior-level GLP experience required.
The predicted salary is between 75600 - 92400 £ per year.
Lead biosafety excellence in a high-impact, Elstree-based role under the Global Pathogen Safety leadership with global influence. You will provide strategic and operational leadership to ensure the successful delivery of Pathogen Safety and GLP Test Facility activities aligned with Global Pathogen Safety strategy and global portfolio objectives. This role is central to maintaining regulatory compliance, driving high standards across non-clinical safety studies, and supporting both lifecycle and new development programmes.
Acting as the key interface between GLP and GMP activities, you will oversee Elstree GLP Test Facility, ensuring full compliance with OECD and MHRA standards and leading inspection readiness. You will build and lead a high-performing team, manage budgets, and contribute to organisational strategy, playing a critical role in protecting patients through pathogen safety within a leading plasma-derived products business.
What You’ll Do
- Lead and manage the Biosafety team at the Elstree site, providing direction to senior scientists and overseeing a team of approximately 9.
- Oversee all GLP Test Facility activities, ensuring alignment with global strategy and full regulatory compliance.
- Ensure all non-clinical safety studies are planned, conducted, and reported in line with OECD GLP and MHRA requirements.
- Act as the primary representative for GLP inspections, ensuring inspection readiness and leading responses to observations.
- Maintain accountability for data integrity, quality systems, and regulatory compliance across Biosafety operations.
- Lead, develop, and motivate a high-performing team, managing both direct and matrix resources.
- Provide technical leadership and troubleshooting expertise across pathogen safety and GLP-regulated activities.
- Partner with internal and external stakeholders, offering expert advice and ensuring effective communication across functions.
- Manage Biosafety budgets and ensure resources are aligned with business and compliance needs.
- Act as the site lead for Biosafety covering health and safety, training, standards, staffing, and KPI performance.
- Support production investigations, change controls, and quality reporting to enable timely batch release.
- Lead regulatory contributions, including filings and responses to health authority questions.
- Maintain awareness of industry best practices in pathogen safety and apply continuous improvement.
- Collaborate across the wider scientific community through knowledge sharing, publications, and conferences.
Qualifications
- Degree (BSc, MSc, or PhD) in Virology, Biochemistry, Biology, or a related field.
- Proven senior-level experience within a GLP-regulated test facility, including Test Facility Management responsibility.
- Strong expertise in GLP regulations (MHRA, EU, US) and their application within biologics.
- Demonstrated experience supporting or leading regulatory inspections (e.g. MHRA or other health authorities).
- In-depth knowledge of pathogen safety, ideally within plasma-derived products or biopharmaceuticals.
- Experience within biopharmaceuticals, plasma-derived products, or relevant CRO environments conducting GLP pathogen safety studies.
- Proven ability to lead complex programmes and cross-functional, multi-site teams.
- Strong leadership, communication, and influencing skills, with the ability to manage complex situations.
- Experience in budget management and resource planning.
- Ability to work in a hybrid model (predominantly site-based) and travel internationally as required.
Head of Biosafety in Elstree employer: Kedrion Biopharma GmbH
Kedrion BioPharma UK is an excellent employer, offering a dynamic work environment in Elstree where innovation and collaboration thrive. With a strong focus on employee development, you will have access to ongoing training and growth opportunities while contributing to meaningful projects that enhance pharmaceutical production. Our supportive culture prioritises safety and compliance, ensuring that you can make a real impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Biosafety in Elstree
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We think you need these skills to ace Head of Biosafety in Elstree
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Kedrion Biopharma GmbH that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Kedrion Biopharma GmbH.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Kedrion Biopharma GmbH does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Kedrion Biopharma GmbH
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Kedrion Biopharma GmbH. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Kedrion Biopharma GmbH's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Kedrion Biopharma GmbH. This shows your passion for the industry!
