Associate Analytical Development Biochemistry

Vor 6 Tagen

Basel, Schweiz We make it Vollzeit

Beschreibung:
We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience.

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.

For our client an international pharmaceutical company based in the Basel region we are currently looking for an Associate Analytical Development Biochemistry

**Associate Analytical Development Biochemistry**:
**Background**

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 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.

**Tasks & Responsibilites**
- Support and maintaining overview of timely delivery of analytical results to the lab
- Consult with satellite labs on pending samples where analysis deadline is approaching
- Management of data returning from satellite labs. Assignment of results to analysis documentation
- Data management in gSheets
- Review and tracking of data/identification of data packages that can be completed
- Shipping of samples to outsourcing partners
- Review of data (after completion of training)
- Support of specific analytical activities (e.g. determination of subvisible particles (HIAC Royco), pH, SoloVPE)
- Depending on workload, cross-group support where needed
- If possible, training and execution of additional analytical methods

**Must Haves**
- Finished Apprenticeship as a Lab technician or Bachelor’s degree in analytics, biochemistry, or biotechnology with a strong focus on analytics (**)
- Min. 2-3 years of professional experience within a laboratory setting within the last 5 years, preferably in the pharmaceutical industry with large molecules, antibodies or biophysical methods (**)
- Experienced in working within a GMP environment and GMP-compliant documentation (**)
- 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
- 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
- Ability to adapt very quickly and work in a dynamic environment

**Nice to haves**
- Hands-on experience in relevant routine analytical methods and analytical development, ideally including subvisible particle and/or HPLC analysis
- Hands-on experience in relevant analytical methods is strongly desired, ideally including subvisible particle analysis (HIAC Royco), pH measurements and protein content determination by SoloVPE or UV-Vis

**Are you interested?

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