Quality Control Project Lead
Elan Personal AGPoste a pourvoir : Quality Control Project Lead
Basel
Elan Personal AG.
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a
Quality Control Project Lead
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, PTD actively collaborates and develops creative technical solutions to bridge early- stage, late-stage and commercial product needs. The mandate of the group is to reliably 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. Synthetic Molecules Technical Development (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and Manufacturing Science & Technology (MS&T), and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small and Large Molecules (PTC, PTB), PTD and MS&T across the manufacturing network. This position on offer is located in Analytical Development Synthetic Molecules within Pharma Technical Development.
Analytical Development is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas
Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of the work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. The QC-Section within the Analytical Development Department is responsible for the Release of Materials based on the GMP compliant execution of Analyses of Inprocess controls, raw materials, intermediates, APIs and Drug products.
Tasks & Responsibilities:
- Work in a modern quality control organization in compliance with cGMP regulations
- Cooperation with internal and/or external partners of Analytical Development
- Active participation in shaping the working methods of the analytical group
- Comprehensive analytical support for supply plants for API and drug product for clinical use
- Critical evaluation of own work results
- Support the analytical group by fulfilling cross-laboratory tasks and project tasks (e.g.reference standard management, CSV business process owner of analytical applications)
- Implementing and fully complying with relevant Roche policies, procedures, and standards in the areas of safety, health, and environmental protection
- Ensuring that laboratory employees are informed of all relevant SHE requirements and their implementation
- Ensuring an appropriate GMP standard in the laboratory
- Scientific and regulatory documentation of the work done
Must Haves:
- Bachelor’s or Master’s degree in Natural Sciences OR a Laboratory Technician with 10+ years of high-level GMP experience
- 3–5 years of professional industry experience with a core focus on Analytical Chemistry
- Practical experience working under cGMP regulations is required
- Proficiency in laboratory-specific software (e.g., Waters Empower, Metrohm Tiamo, or Labware LIMS)
- English (Fluent/Mandatory). German language skills are considered a significant advantage
Nice to Have:
- Roche Experience
- Experience in roles such as Lab Head, Analytical Project Manager, or equivalent
What you will be offered:
- An opportunity to work in one of the world's most important pharmaceutical companies
- Modern campus with plenty of green spaces and meeting areas
- Central location in Basel
- Varied job profile
- Further training opportunities through temptraining
- Working in a dynamic and motivated team
If you are interested please send your application documents addressed to Ms Diana Afonso.
Basel-Stadt Aargau Pharma Science GMP Quality Control QC-PL Laboratory Waters Empower Metrohm Tiamo LIMS
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