Skills

A pharmaceutical scientist with a broad scope of knowledge in regulatory guidelines, training programs in ICH, GMP, FDA guidelines, preformulation and formulation experience, statistical analysis and health economics and outcomes research (HEOR) modeling

1) Preformulation and formulation of dosage forms using Quality-by-Design (QbD) and Process Analytical Technology (PAT) principles

2) HEOR: model building and development, Systematic Literature Review (SLR) and meta-analysis (MA)

3) Statistical analysis: development of statistical analysis plan (SAP) for clinical trials/studies, statistical analysis of study data, statistical process control (SPC) for manufacturing processes, validation of patient-reported outcome (PRO)

Refrences

1) Teaching assistant at Duquesne University, USA: taught pharmaceutical compounding practices to undergraduate PharmD students

2) Head of Quality at pharmaceutical and life sciences consulting company in Mumbai: deveoped in-house quality-related SOPs, training programs for pharmaceutical company clients on ICH, FDA and QbD guidelines, statistical analysis of clinical studies and development of statistical analysis plans (SAP), meta-analysis, developed health economic models to ascertain cost-effectiveness of interventions for multinational pharmaceutical companies, statistical handling of out-of-trend data in manufacturing processes, response to FDA warning letters by reviewing drug manufacturing data

Time and Spatial Flexiblity

Would like to freelance and be based out of Mumbai, India

Open to travel for project delivery and as required

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