CMC Scientist - Bern, Schweiz - We make it GmbH

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, scale-up, technology transfer, process validation, CMC regulatory affairs, and / or MS&T
• A digital expertise with hands-on 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 decision-making driving cross-functional 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

• 41 h Week

Are you interested?

Then Mr André Amstad looks forward to receiving your complete application ocuments (CV, references and training certificates).

We look forward to hearing from you.

Seit 2003 verleiht und vermittelt die we make it GmbH Mitarbeiter und Mitarbeiterinnen im Bereich Pharma – Chemie, Logistik und IT. Die we make it GmbH stellt höchste Ansprüche an Qualität, Ethik und Diskretion, Testen Sie uns