Expert Science & Technology (Oral Solid Dosage forms)

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:

• 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.

Work Experience:

• Functional Breadth.
• Operations Management and Execution.
• Collaborating across boundaries.

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.