Schweiz, Basel-Stadt, Basel Headquarter
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"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.
“Europe Biologics“ (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 Europe' (PTDE-A) 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 Principle Associate Analytical Development Biochemistry is responsible for:
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
Coordination of analytical activities including sample management for biotechnological development products
Analysis of drug product formulations under Good Manufacturing Practice (GMP) conditions
Together with the group members and representatives from other departments, 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.
Your Profile
For this interesting challenge, you bring the following qualification:
Master or Bachelor degree in analytics, biochemistry, biotechnology or similar scientific qualification
1-3 years experience in biopharmaceutical industry with strong focus on analytics, preferable in a GMP environment
Experience in HPLC analytics is preferred
Self-motivated, pro-active, responsible, result-oriented and an excellent team player
Excellent communication skills in English and German (written and spoken)
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