You analyze drug formulations and particles while coordinating samples and analytical activities. You will also support method validation and ensure compliance with GxP guidelines through proper documentation and procedures.
Anforderungen
- •Lab technician with 1-3 years experience
- •Vocational scientific qualification or Bachelor's degree
- •Hands-on experience in HPLC analytics
- •Self-motivated and excellent team player
- •Preparedness to apply novel software tools
- •Good written and spoken English
Deine Aufgaben
- •Analyze drug product formulations under GMP conditions.
- •Evaluate visible and subvisible particles.
- •Coordinate analytical activities and sample management.
- •Support development and validation of analytical methods.
- •Maintain GxP-conform analytics and proper documentation.
- •Author GMP documents, including analytical procedures.
Original Beschreibung
# (Senior) Associate Scientist (2- year fixed- term, Basel)
**Basel** | **Full time**
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.
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### The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
## *The Opportunity:*
Pharma Technical Development Europe Biologics brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. Our daily work also includes compiling of regulatory documents and the transfer of development projects to commercial manufacturing.
***Who we are:***
We are striving for a caring and sensing network organization, which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and "getting it done" mentality. The benefit for the patient is in the centre of our thoughts and efforts. The department 'Analytical Development and Quality Control Biotech Europe' 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) Associate Scientist is responsible for:*
* Analysis of drug product formulations under GMP conditions (HPLC, compendial methods)
* Analysis of visible and subvisible particles
* Coordination of analytical activities, including sample management for biotechnological development products
* Support of development, improvement and validation of analytical methods for the quality assessment of active substances and galenical forms
* Maintaining efficient and timely GxP-conform analytics and documentation following the current GxP guidelines as well as the relevant SOPs
* Authoring of GMP documents, e.g. analytical procedures, validation reports
## *Who you are:*
* Lab technician with at least 1-3 years experience in the pharmaceutical industry with a strong focus on analytics, preferable in a GMP environment
* Vocational scientific qualification (e.g. apprenticeship) or Bachelors degree in analytics, biochemistry, biotechnology or related fields is required
* Hands-on experience in HPLC analytics is 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 mandatory
* Good written and spoken English is a must, and knowledge of German is an advantage.
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# Who we are
A healthier future drives us to innovate. Together, more than 100’000 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.
Let’s build a healthier future, together.
**Roche is an Equal Opportunity Employer.**