Cmc Scientist - Bern, Schweiz - We make it GmbH

We make it GmbH

Geprüftes Unternehmen

Bern, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector.

Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, the company CSL Behing in Bern, we are looking for a CMC Scientist & Digital Enabler (M/F/d).

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders.

The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

Aufgaben

Run small Expert Teams to compile Quality by Design and regulatory dossier information
Compile Quality by Design information
Compile CMC regulatory dossier information & PACMP protocols / reports
Enable/direct internal department digital improvement initiatives encompassing: interactive training material, global portals, project reporting tools and dashboards, process flow data mapping.
Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives

Qualifikation

Education in Pharma
Large or Small Molecules, MedTech
5+ years experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (MedTech, electronics)
Project coordination/leadership; enjoys leading teams to achieve quality results in a defined timeframe.
QbD, process development, scaleup, technology transfer, process validation, CMC regulatory affairs, and / or MS&T
A digital expertise with handson experience focussed on advanced data management / data processing / data analytics in a life sciences area
Have experience in interpreting, visualising and communicating complex project data to facilitate collaborative decisionmaking driving crossfunctional business outcomes
Knowledge of regulatory actiivies and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus
English: Spoken & excellent writing skills required
German: spoken & written is an asset

Work hours