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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 Senior/Principal Associate Analytical Development Biochemistry is responsible for:

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

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 is a must and knowledge of German is an advantage.

How to Apply:

Please upload your CV, cover letter, and vocational training certificate or diploma.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.