Expert Science & Technology

Job Description Summary

Design, plan, perform, interpret and report the analytical results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within global ARD. Expertise in analytical method development, method validation as well as technical and strategic background. Manage technical lab/plant activities. Execute the analytical experiments in line with TRD vision. Ensure full portfolio support in line with GDD, NTO and NIBR plans. Maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

 

Job Description

Major accountabilities:

• 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.
• Support internal and external audits and ensure no critical findings within the
  assigned scope.
• Actively contribute to team and organization goals.
• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis
  Guidelines.
• Additional specific roles/tasks: See Up4Growth training assignments for the
  business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth).

Minimum Requirements:
Work Experience:

• 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:

• Environment.
• Experiments Design.
• Health And Safety (Ehs).
• Laboratory Equipment.
• Manufacturing Process.
• Materials Science.
• Process Simulation.
• Project Management.
• Sop (Standard Operating Procedure).
• Technical Writing.

Languages :

• English.

 

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model