Expert Science & Technology (ARD)

Major accountabilities:

• Independently plan, organize, execute, and document scientific experiments (e.g., stability/ release testing, validations, APS, etc.) according to the agreed timelines and appropriate quality standards.
• Accountable for documentation and submission of raw data in appropriate data system (e.g., GLIMS eLN).
• Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
• Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
• Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/glassware management etc.).
• Review and verify raw data generated by others; approval of tests/experiments performed by others; write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision.
• Train and coach associate scientists, technicians, temporary employees and employees under training/education.
• Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
• Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Actively contribute to team and organization goals.
• Work according to appropriate SOPs, GMP, HSE, ISRM and Novartis Guidelines.

• Bachelors/Masters in Life Science (e.g., analytical/organic chemistry/pharmacy/pharmaceutical development) or equivalent
• 3+ years of related experience in a GMP environment
• Understanding of general regulatory and quality expectations
• Good scientific background, communication skills including presentation and scientific/technical writing
• Fluent English (Oral and written)