Associate Principal Scientist, Analytical Development and QC
Proclinical are recruiting for an Associate Principal Scientist, Analytical Development and Quality Control to join a pharmaceutical organisation. This role is on a permanent basis and is located in Vaud.
- You will plan stability studies and outline shelf-life of GMP products, review and characterise impurities etc.
- Produce crucial data to assist protein characterisation and comparability studies.
- Prepare, evaluate and file analytical CMC source documents for clinical trial application (quality section), serving as a support to CMC regulatory affairs.
- Contribute to the selection of pertinent CDMOs/CROs by evaluating the suggested analytical packages.
- Offer crucial knowledge within the development of the company.
- Partake in the biotech programs method in a matrix setting with the view to speed time to clinic.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to an advanced degree level in a biochemistry, analytical chemistry, or similar discipline with pertinent industry experience within biologics R&D.
- Demonstrable experience within a biotech manufacturing organisation in numerous stages of project development, working within practical analytical development roles in multidisciplinary teams.
- A background in development and validation of methods of analytical characterisation, mass spectrometry, bioassay of antibodies and ADCs.
- Acquaintance with large molecule and protein characterisation.
- Prior involvement with comparability studies.
- Comprehension of the international development of biologicals from preclinical to late-stage clinical development.
- Comprehension of the management of a network of CDMO's and CRO's.
- Experience of regulatory and quality regulations suitable for investigational medicinal products and biologics.
- A scientific curiosity, flexibility, and capable of identifying and solving multifaceted scientific issues.
- A high attention to detail.
- Interpersonal and communication skills both verbally and in writing.
- Works well in a team.
- Capable of distributing multifaceted goals under challenging timelines within a rapidly changing setting.
- Fluency in the English language.
If you are having difficulty in applying or if you have any questions, please contact Patrick Turbidy at email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.