Scientist Regulatory Bioanalysis of Large Molecules

Job description

  Job facts

As part of the Roche Pharma Research and Early Development organisation in Basel, the department of Global Clinical Pharmacology and Bioanalytical R&D, within the unit Pharmaceutical Sciences is responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinical development. The group of Large Molecule Regulated Bioanalysis acts as an interface for the conduct of large molecule bioanalytical development projects in cooperation with external contract research organizations (CROs), various internal pre-clinical and clinical stakeholders and health authorities.

We are looking for a highly motivated scientist to join our function for the bioanalysis of large molecules, i.e. biologics, LNAs, peptides and ADCs. The core tasks of our Regulatory Bioanalysis group are the quantification of drug and soluble target and the detection and characterization of immunogenic reactions against the drug. This is done along the full value chain, from the pre-clinical stage up to market. You will be part of a team that is responsible for the oversight of scientific tasks in in the field of Regulated Bioanalysis. In most cases, our bioanalytical studies are conducted at CROs according to current regulatory guidances. As a Bioanalytical Manager, you will be responsible for

·  designing bioanalytical method validation strategies
·  the transfer of bioanalytical methods to CROs and their validation
·  the conduct of associated scientific tasks, such as data reviews, support in the interpretation and understanding of bioanalytical results in cooperation with other functions
·  maintaining contacts to CROs and internal partners, representing regulatory bioanalytical expertise in project teams where required
·  regulatory compliance (GLP/GCP) of all conducted work, including documentation
·  the constant scientific evolvement of our Bioanalytical Function with respect to regulatory aspects
·  reaching out to health authorities to discuss, align and evolve our bioanalytical strategy
·  the support of regulatory submissions

You have completed your PhD or equivalent studies in (Bio-) chemistry or Biology. You have demonstrated strong communication skills to negotiate technical details with experts equally well as to internal stakeholders and health authorities while retaining a scientific oversight.. Ideally, you have already gained some experience in bioanalytical work for large molecules including immunogenicity testing.

Your English is excellent, both written and spoken. Fluency in German will be an asset. You are familiar with standard office software. Your strengths are attention to detail, dedication, flexibility, communication and teamwork.

For further information, please contact Recruiting Team Switzerland , phone

If you are interested in this position, please apply online and attach full supporting documentation (CV, diplomas etc.).

Roche is an equal opportunity employer.
Research & Development, Research & Development > Pharmacology

·  Who we are

Roche is an equal opportunity employer.