1. Roles and Responsibilities:

a. Responsible for literature search, formulation and process development of oral solid, Liquid, topical and multiparticulates.

b. Basic understanding and knowledge of guidelines of stringent regulatory agency (USFDA, EU & Japan), ICH and DCGI.

c. Good understanding and exposure of product development for screening and for optimization of formulation as well as process parameters.

d. Design and manage formulation trials, analytical testing and evaluate stability data to finalize formulation composition.

e. Develop manufacturing processes for R&D; formulations so that the technical transfer is successful for large scale batches.

f. Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.

g. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.

h.



Execution of manufacturing of exhibit/submission batches per regulatory requirements.

i. Support technology transfer for manufacturing processes from laboratory scale to production scale.

j. Work with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of recent products.

k. Assure that all formulation and process development activities are documented in the lab notebook as per company procedures and GDP.

l. Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.

m. Actively participate in obtaining patents for products and processes.

n. Good hands on MS word, excel and power point.

1. Educational qualifications/Experience

Master in Pharmacy (Pharmaceutics) with 7-10 years of related work experience

📌 Research Scientist F&D at P&C R&D (Haridwar)
🏢 Akums Drugsu0026 Pharmaceuticals
📍 Haridwar