Expert Science & Technology

Key Responsibilities

• Responsible for performing method feasibilities and validation of robust analytical methodologies applied to innovative oral solid dosage forms. Strong experience in chromatography techniques and experience in handling techniques like Dissolution, Titrator etc., used for OSD testing is a pre-requisite.
• 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 an 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.
• Generate and 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.

Minimum Requirements

• Ph.D. in Analytical Chemistry or an equivalent qualification with a minimum of 1–3 years of experience, or M. pharm/M.Sc. with at least 8 years of experience within the pharmaceutical industry, specifically in analytical development.
• Understanding of general regulatory and quality expectations. GMP experience is a must
• Good scientific background, communication skills including presentation and scientific/technical writing.
• Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc.
• Expertise in liquid chromatography separation techniques and dissolution techniques is a pre requisite. Experience in Mass Spectrometry (ranging from mass confirmation to actual quantitative analysis of impurities and sequencing) is an asset.