At a Glance
- Tasks: Lead analytical development strategy for biosimilar monoclonal antibodies and ensure robust characterisation.
- Company: Growing biopharma organisation with a focus on innovative biosimilars.
- Benefits: Visa support for international applicants, competitive salary, and career growth opportunities.
- Other info: High-visibility role with technical leadership and global experience.
- Why this job: Make a real impact in biosimilars and shape the future of biopharma.
- Qualifications: Experience in biosimilars analytical development and strong understanding of mAb structure.
The predicted salary is between 70000 - 90000 £ per year.
Biosimilar mAb Characterisation Strategy
London | On-site | Monday - Friday
BioTalent are partnered with a growing biopharma organisation strengthening its analytical development capability within a global biosimilars portfolio. This is not routine analytical testing. This is about building and defending a robust biosimilarity and analytical similarity strategy across monoclonal antibody programmes. The focus is deep molecule-level understanding, structural characterisation and regulatory‑defensible data packages.
The Role
You will lead analytical development strategy for biosimilar mAbs, with responsibility across:
- Analytical similarity and biosimilarity assessment frameworks
- Comprehensive physiochemical characterisation of monoclonal antibodies
- Establishment and optimisation of HPLC methods including: Glycan profiling, CEX, SEC, Protein A, HIC
- Capillary electrophoresis techniques including cIEF and CESD
- LCMS data interpretation for PTM identification and structural analysis
- Impurity profiling and degradation pathway assessment
- Method development, qualification and lifecycle management
- Statistical analysis and use of DoE in analytical method optimisation
- Support of Module 3 analytical content for IND, IMPD, BLA and MAA
- Interaction with Regulatory Affairs on EMA, MHRA and FDA queries
You will act as the analytical SME in cross‑functional stage gate reviews, challenging interpretations and ensuring analytical conclusions are scientifically defensible. This role is technical leadership rather than daily wet‑lab execution. You may not run assays yourself every day, but you will design the strategy, review the data and direct the technical path.
Qualifications
- Direct biosimilars analytical development experience
- Demonstrated experience in analytical similarity and biosimilarity assessment
- Strong understanding of mAb structure, PTMs and higher‑order structure
- Deep expertise across HPLC and CE platforms
- Ability to interpret LCMS data for structural differences
- Experience supporting regulatory submissions with analytical content
- Experience leading or mentoring analytical scientists
Not Suitable For
- QC analysts focused on release testing
- Small molecule analytical chemists
- Scientists without biosimilars exposure
- Pure people managers lacking technical depth
Why Move
In biosimilars, analytical similarity is the battleground. This role owns how molecules are characterised, compared and defended. It is a high‑visibility position within a growing technical site backed by global experience.
Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa SupportAvailable in London employer: BioTalent
Join a pioneering biopharma organisation in London that is at the forefront of biosimilar development, where your expertise will shape the future of monoclonal antibody characterisation. With a strong emphasis on employee growth and a collaborative work culture, you will have the opportunity to lead innovative projects while benefiting from visa support for international applicants. This role not only offers a chance to make a significant impact in the field but also provides a supportive environment that values technical leadership and professional development.
StudySmarter Expert Advice🤫
We think this is how you could land Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa SupportAvailable in London
✨Get Involved in Local Research Communities
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We think you need these skills to ace Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa SupportAvailable in London
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 BioTalent 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 BioTalent.
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How to prepare for a job interview at BioTalent
✨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 BioTalent. You might even be asked to demonstrate your understanding of these processes.
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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.
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