Quality Control Project Lead / Quality Control Project Leadess

Quality Control Project Lead

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, hosting vital research and development functions. For our esteemed client, F. Hoffmann-La Roche AG, located in Basel, we are currently seeking a Quality Control Project Lead.

Background:

The Global Technical Development (PTD) organization, comprising over two thousand dedicated professionals worldwide, plays a crucial role in Roche's mission to develop meaningful medicines for patients. PTD collaborates closely to devise innovative technical solutions that address the needs of early-stage, late-stage, and commercial products. Our commitment is to reliably deliver a robust pipeline and supply quality products to our patients, driven by innovation, teamwork, dedication, and mutual respect.

The Synthetic Molecules Technical Development (PTDC) group possesses extensive experience across drug substances (DS), drug products (DP), analytical sciences, and Manufacturing Science & Technology (MS&T). They work in close partnership with key stakeholders in Research and Early Development (pRED/gRED), Small and Large Molecules (PTC/PTB), PTD, and MS&T throughout the manufacturing network. This position is housed within the Analytical Development Synthetic Molecules team under Pharma Technical Development.

Analytical Development is responsible for the creation of cost-effective and resource-efficient analytical methods for all materials involved in drug manufacturing, utilizing cutting-edge methodologies such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), and Mass Spectrometry (MS). The goal is to establish a robust control strategy for releasing pharmaceutical products for clinical trials and ultimately for commercial distribution. The QC Section within Analytical Development ensures the release of materials based on GMP-compliant analyses of in-process controls, raw materials, intermediates, APIs, and drug products.

Tasks & Responsibilities:

• Operate within a modern quality control organization, adhering to cGMP regulations.
• Collaborate with internal and external partners in Analytical Development.
• Actively contribute to the development of analytical group work methodologies.
• Provide comprehensive analytical support for supply plants regarding APIs and drug products for clinical use.
• Critically evaluate personal work results.
• Support the analytical group in cross-laboratory and project tasks, such as reference standard management and CSV business process ownership for analytical applications.
• Implement and comply with Roche's policies, procedures, and standards concerning safety, health, and environmental protection.
• Ensure all laboratory employees are informed of relevant SHE requirements and their implementations.
• Maintain appropriate GMP standards in the laboratory.
• Prepare scientific and regulatory documentation of conducted work.

Must Haves:

• Bachelor's or Master's degree in Natural Sciences, or a Laboratory Technician with over 10 years of high-level GMP experience.
• 3–5 years of professional industry experience focusing on Analytical Chemistry.
• Practical experience in a cGMP environment is mandatory.
• Proficiency in laboratory-specific software (e.g., Waters Empower, Metrohm Tiamo, or Labware LIMS).
• Fluency in English (mandatory); German language skills are considered a significant advantage.

Nice to Have:

• Previous experience with Roche.
• Roles such as Lab Head, Analytical Project Manager, or similar positions.

What You Will Be Offered:

• An opportunity to work with one of the world's leading pharmaceutical companies.
• A modern campus with ample green spaces and meeting areas.
• A centrally located office in Basel.
• A diverse job profile.
• Further training opportunities through temptraining.
• The chance to work in a dynamic and motivated team.

If you are interested in this position, apply online using the form below. Please note that only applications matching the job profile will be considered.