Your new company
A global biotechnology company that researches and develops biological therapeutics for infectious and autoimmune diseases. They are a leading ATMP-focused company that is going through a massive period of growth.
Your new role
* Develop and conduct In-Use Stability studies to evaluate device compatibility for clinical use.
* Perform assays to assess the characteristics, quantity, identity, activity, and purity of administered drug products.
* Make recommendations on suitable patient delivery systems for biopharmaceuticals.
* Ensure precision in data recording and critically analyse data for regulatory submissions.
* Advise clinical sites on potential patient safety issues.
* Collaborate closely with formulation team members, CMC teams, and related functions.
* Contribute to formulation-related sections in regulatory filings, development reports, and other relevant documents.
What you'll need to succeed
* Skilled in plate-based assays such as ELISAs and MSD assays.
* Proficient in working independently with accuracy and precision.
* Expertise in sub-visible particle analysis and other compendial techniques, including pH measurements, Western Blotting, SDS PAGE, and core lab techniques.
* Experienced in In-Use Stability studies and knowledgeable about clinical devices in the IV infusion process.
* Familiar with principles of biopharmaceutical stability studies.
* Acquainted with various drug delivery formats.
* Proactive in maintaining high-quality work and taking on additional responsibilities to achieve team goals.
* Delivered detailed scientific findings and papers to both internal and external audiences.
What you'll get in return
* Flexible working options
* Competitive rate of pay
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
#J-18808-Ljbffr