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Jobs

Associate Analytical Development Biochemistry (LSB)

Anzeigen ab:
21.10.2021
Jobtitel:
Associate Analytical Development Biochemistry (LSB)
Datum:
21.10.2021
Beschreibung:

We make it GmbH is a company operating nationally in Switzerland. Thanks to many years of successful experience, it has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

Background:

Global Technical Development (PTD) is an Organisation 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 innovative 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.

Task and Responsibilites :

Routine analysis of drug product release and stability samples under GMP conditions (e.g. State, pH, Opalescence/Turbidity, Density, Protein Content, Osmolality, etc.), 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 reports, analytical procedures, validation reports, Support of the development, improvement and validation of analytical methods for the quality assessment of active substances and galenical forms.

You must have these qualifications :

Finished Apprenticeship as Lab technician or Bachelor’s degree in Life Sciences or similar, Min. 1-3 years professional experience within laboratory setting, preferably in pharmaceutical industry, Experienced in working within GMP environment and GMP-compliant documentation, Hands-on experience in relevant routine analytical methods and analytical development, ideally including subvisible particle and/or HPLC analysis, Technical flair and strong IT skills (MS Office, G-Suite), Very good command of German verbally in written is necessary and knowledge of English is a big advantage.

Nice to haves :

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, Interest to support digital transformation initiatives, Experience in particle analysis.

Region:
Region Basel
Kategorie:
Technische Berufe
Branche:
Chemie/Pharma

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