Cmc Scientist

vor 6 Monaten

Bern, Schweiz We make it GmbH Vollzeit

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?

We look forward to hearing from you.

  • Global Regulatory Affairs Cmc Scientist in The

    vor 6 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    Do you want to work in a global team and support worldwide registrations for Albumins? The Global Regulatory Affairs CMC Scientist is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The...

  • Principal Scientist in Plasma Product Development

    vor 5 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    Within Plasma Product Development, we develop novel, high quality plasma-derived therapies that improve the health and well-being of our patients around the world. Our ability to innovate and deliver life-saving medicines for these individuals living with rare diseases and other unmet medical needs has earned us a reputation for always putting patients...

  • Scientist - Biopharma R&D - Pathogen Safety

    vor 5 Monaten

    Bern, Schweiz Eurofins Vollzeit

    Job Description Providing guidance on and co-development of pathogen reduction steps for new products in development and for Life Cycle of existing commercial products Evaluating experimental results and contribute to establishment of CMC, Quality by Design, e.g. definition of targets, robustness ranges and critical parameters Collaborating with...

  • Associate Director Bioprocess Development for

    vor 5 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. With over 1,400 employees we develop and manufacture plasma-derived therapies at our facilities in Bern to deliver them to patients worldwide. For our location in Bern, we are looking for: **Associate Director,** **Bioprocess Development for plasma-de**riv**ed...