Major Accountabilities:

•Design, plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance.

 Monitors degradation pathways and shelf-life of products.

Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.

•Adhere to Quality metrics, Compliance and Good Documentation Practices following ALCOA+ principles, GLP, OQM, HSE, ISEC and Novartis guidelines.

•Should be a Team player by adding value in collaborating with other teams to support project deliverables within agreed timelines, mentoring new joiners, active participation in project meetings / networks / meetings and contributing to Team goals while meeting individual objectives.

•Responsible for Qualification of instruments / equipment’s (URS to Report) and periodic calibrations as per applicable site procedures.

Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory

•Ability to perform investigations, guide team members, communicate proactively and clearly to global stakeholders.

Cross-functional collaboration  

What you bring to the role:

•Broad scientific or technical knowledge in a specific area.

•Adequate understanding of development processes in own function.

•Advanced knowledge of laboratory and/or technical tools.

•Good knowledge of software and computer tools.

•Proficient in literature searches

Good understanding about Regulatory Guidelines

Strong problem-solving and critical thinking 

Knowledge on ICH guidelines (Q2(R1)), QbD principles etc

Minimum requirements:

•Minimum: M. Pharm./M.Sc. Good knowledge of English (oral and written).

•PhD on technical subject with 4+yrs of relevant experience. or Master of Science with 12+ years of relevant experience in testing of Solid oral dosage forms.

•Good presentation skills and scientific/technical writing skills.

•Good communication skills