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.

Responsibilities:

• 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 p.turbidy@proclinical.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.

#TechOps