Associate / Senior Associate Analytical Development Biochemistry (temporary for 3 years)
Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
Pharma Technical Development Europe Biologics (PTDE) 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 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 Associate / Senior Associate Analytical Development Biochemistry is responsible for
Development, improvement and validation of analytical methods for the quality assessment of active substances and galenical forms
Routine analysis of drug product release and stability samples under GMP conditions
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
Evaluation of new technologies/methods and support of innovation projects
For this interesting challenge, you bring the following qualification:
Lab technician with 1-3 years’ experience in the pharmaceutical industry or Bachelors degree in analytics, biochemistry, biotechnology with a strong focus on analytics, experience in a GMP environment is preferable
Hands-on experience in relevant analytical methods is required, ideally including subvisible particle and/or HPLC analysis
self-organizing way of working and the ability to interact and cooperate across matrix organizations and departments/functions
Self-motivated, proactive, responsible, result-oriented and an excellent team player
Strong IT skills or interest to support digital transformation initiatives are a plus
Good command of German is a must and knowledge of English is a big advantage
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