Senior/ Principal Associate Scientist
vor 2 Wochen
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.
The Position
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. 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 center 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 Opportunity:
- Analysis of drug product formulations under GMP conditions (HPLC, compendial methods)
- 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
- Evaluation of new technologies/methods and support of innovation projects
- Planning and monitoring of the work packages to ensure efficient analytics and continuous improvement
- 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, change control documents
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 or is required
- Hands-on experience in HPLC & excipients (e.g. Polysorbates & Poloxamers) 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 and German is a must
Roche is an equal opportunity employer. If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organisation for you. Every role at Roche plays a part in making a difference to patients' lives. If you want to work in a passionate team, make your mark & improve lives, apply now
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.
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