associate scientist qc release & stability.

Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 40,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 400 people of over 25 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products.

For our site in Bern, we are looking for an open minded, goal driven, motivated Associate Scientist QC Release & Stability.

QC Release & Stability is involved in the validation and transfer of various test methods and the performance of routine release and stability tests for new materials in the clinical and commercial phase. The chemical methods used internally include chromatographic methods (RP, SEC, IC), TOC, Conductivity and biochemical methods as qPCR, Capillary Electrophoresis, SDS-PAGE, ELISA, Dot Blot etc.

Responsibilities/tasks

• Responsible for performing various chemical and biochemical testing according to internal and/or regulatory standards (EP, USP, ISO, other) for QC testing
• Responsible for release, in-process control and stability testing
• Responsible for performing utility monitoring tests (water-monitoring samples)
• Perform method co-validations, qualification and verifications
• Analyses and reports test results
• Maintain current laboratory equipment and operates analytical and other instruments
• Perform laboratory duties to support department objectives Support the Quality
• Control department in internal and external audits and requests
• Responsible for compliance with Quality goals for this position
• Provide support to analytical development, process development and other stakeholders when the need arises
• Support training and qualifications of team personnel
• Support timely and effective completion of lab events, investigations and CAPAs related to OOS and non-conformances
• Lead and support continuous improvement projects within Quality Control in operational efficiency and GMP compliance Complies with all applicable health, safety and environmental regulations, processes and guidelines
• Provide support to analytical development, process development and other stakeholders when the need arises