Assoc. Scientist – Technical Development Full-time

Job Title

Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab instruments/infrastructure.

Support development projects aiming the development of stable, bioequivalent, robust and cost competitive dosage forms. Design and manage experiments/batches for simple/low complexity products under supervision, provide related scientific documentation. Plan and execute experiments in agreement with quality risk management and GDevP /GMP. Assists in the preparation of and reviews of the technological part of dossier.

Key Responsibilities

• Plan, 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.
• 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).
• Accountable 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 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.

Essential Requirements:

• Strong expertise in Chromatography and Dissolution Testing, including method selection and handling
• Proven experience in Analytical Method Development, Validation, and Transfer
• Solid understanding of Regulatory Compliance and GLP standards
• M.Pharm./M.Sc. with up to 2 -5 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

Environment, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure)