Analytical Methods Development (m/f/d)
- Develop and validate analytical methods
- Characterize products, standards, and impurities
- Review lab data, SOPs, protocols, and reports
- Author CoAs, technical reports, and regulatory documents
- Monitor reference standards and stability programs
- Lead CDMO interactions and internal collaborations
- Support BLA/MAA documentation and regulatory responses
- Contribute to budget forecasts and development plans
- Advanced degree in chemistry, biochemistry, life sciences, or engineering
- 7+ years in method validation and analytical transfers
- 2+ years in cGMP QC in pharma/biotech
- Hands-on experience with bioanalytical techniques (e.g., HPLC, CE, ELISA)
- Strong knowledge of GxP, ICH, and regulatory standards
- Proficient in statistical tools (JMP/Minitab), Microsoft Office
- Project management and CDMO collaboration experience
- Fluent in English
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.