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At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
Global Technical Development (PTD) actively collaborates and develops innovative technical solutions to efficiently transform scientific ideas into products. The mandate of the group is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation collaboration dedication and mutual respect and contributes every single day continuously improving what it does.
PTDE supports biologics from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP) market formulation design and process development device development clinical manufacturing of DS and parenteral DPs analytical method development validation and release of clinical supply development documentation submissions and transfer of development projects to commercial manufacturing.
The department Analytical Development and Quality Control Biotech is responsible for Biochemical Analytical Development Quality Control and Compliance required for Analytics of Biopharmaceuticals from pre IND ( Investigational New Drug) to BLA (Biologics License Application) and Launch.
The Senior/Principal Associate Scientist Analytical Development and Quality Control is responsible for the following tasks:
Develop improve and validate analytical methods for the quality assessment of drug products.
Perform a variety of analytical techniques including chromatography electrophoresis and particle analytics under GMP conditions.
Coordinate analytical activities and manage samples for innovative biotechnological development products.
Collaborate with team members and cross-functional partners to plan and monitor work packages drive efficient analytics and continuous improvement.
Author key GMP documents including analytical procedures and validation protocols/reports
Take ownership of analytical instruments including their qualification maintenance and documentation.
For this interesting challenge you bring the following qualification:
You either have a Masters/Bachelors degree (Analytics Pharmacy Biochemistry Biotechnology OR You have completed vocational scientific qualification (e.g. apprenticeship) with 13 years experience in the pharmaceutical industry with a strong focus on analytics preferable in a GMP environment
Experience in Electrophoresis and/or HPLC analytics preferred
Self-motivated proactive responsible result-oriented and an excellent team player
Preparedness to apply novel software tools to increase efficiency in data handling is a plus
Experience with statistical software (e.g. R JMP Spotfire) is a plus
Excellent communication skills in English and fluent in German
The position is temporary for 2 years.
To apply please submit a cover letter your current resume and your official educational certificates or proofs.
Apply now were excited to hear from you!
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Staff IC
Full-Time