Novartis
Designation : Expert
Function : Science and Technology, R&D
Functional Area : Oral Solid Dosage forms
Job Role Summary : Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals
Job Profile :
- Plan, organize, execute, and document scientific experiments (e.g., analytical
method developments/ validations/ transfers/ stability/ release testing, formulation
development analytics etc.) according to the agreed timelines and appropriate
quality standards.
- Accountable for documentation and submission of raw data in appropriate data
system (for e.g., LIMS test activation and results entry).
- 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.).
- Responsible for implementation and maintenance of lean/efficient/environmentally
sustainable practices in the laboratory.
- 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.
Job Requirements :
- Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent.
- 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc.
- Fluent in English (oral and written).Knowledge of site language, if required.
- Knowledge in quality principles driving drug development such as GMP.
- Understanding of general regulatory and quality expectations.
- Good scientific background, communication skills including presentation and scientific/technical writing.
- Skills Desired: Experiments Design, Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Model
Work / Job Experience : 5+ Years
Type of Experience : Analytical method developments/ validations/ transfers/ stability/ release testing, Formulation development analytics etc.
Academic Qualifications :
Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent.
