Archana Kapse

Pharmaceutical professional with 5 years of experience in drug development, formulation and CMC regulatory strategy at industry leaders such as Novartis and Dr. Reddy's Laboratories. Proven expertise in developing complex formulations, preparing regulatory submissions (ANDAs, INDs), and cross-functional collaboration across clinical, analytical, and IP teams.

Recently upskilled in data-driven product strategy through a Product Management Certificate from the Indian School of Business, with hands-on proficiency in Power BI, and experimentation frameworks. Passionate about leveraging domain expertise and analytical tools to drive strategic decision-making in the pharmaceutical industry.

Formulation Development Scientist at Novartis Healthcare Ltd (2024-02 – Present)

Formulation development to enable early and late phase Oral solids and injectable products. Formulation development is closely integrated with other department such as pharmacokinetics, clinical development, and regulatory affairs to ensure holistic approach to drug development.

• Working on development of Clinical Service Form (CSF) to filing NDA application.
• Coordinated with third-party manufacturing sites for technology transfer and scale-up activities
• Market-US, Japan, China, Europe and Africa

Formulation Development Scientist at Dr. Reddy's Laboratories Ltd. (2021-08 – 2024-02)

Carried out lab scale & scale up development activities of complex generic drug-device combination products like nasal sprays & on a sterile products like injectable emulsion and Lyophilized Nano injectable suspension.

• Filed a BIO-IND application for complex injectable product and ANDA for Drug-Device combination product.
• Provided technical due-diligence before product introduction by coordinating with CFTs like process development, analytical research & development, regulatory affairs (RA), IP, ideation, and transfer site teams.
• Prepared & reviewed risk assessment, justification of specification, specifications, elemental risk assessment, residual solvent risk assessment, nitrosamine risk assessment, DDCP, PDR, CMC studies, BABE studies, stability data compilation, and additional stability protocol documents.
• Market- US, Europe, Canada, and China

Master of Pharmacy in Pharmaceutics – Institute of Chemical Technology, Mumbai (2019-06 – 2021-06)

Bachelor of Pharmacy in Pharmacy – Savitribai Phule Pune University (2015-06 – 2019-06)