Job Description Summary

Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. - Execute the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD: -Design, plan, perform, interpret and report results of scientific experiments for the development and timely delivery drug products (DP), processes and procedures. Lead and manage all project/local network activities.

 

Job Description

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.

Essential Requirements:

• Strong expertise in Chromatography and Dissolution Testing, including method selection and handling
• Proven experience in Analytical Method Development, Validation, and Transfer and multimedia dissolution
• Expertise in method validation, method transfer, IcH guideline, HPLC and UPLC.
• Solid understanding of Regulatory Compliance and GLP standards
• M.Pharm./M.Sc. with 4 -8 years of relevant experience, with demonstrated experience in a related domain.

Desirable Requirements:

• Understanding digital tools
• Hands on experience with GLIMS, Chromeleon and ELN

 

Skills Desired

Design of Experiments (DOE), Environment Health and Safety, Environment Management, Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Model