Research Scientist F&D at P&C R&D

Akums Drugs & Pharmaceuticals Limited; Haridwar; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Akums Drugs & Pharmaceuticals Limited is seeking a senior formulation scientist to lead literature search, design and optimize formulations for solid, liquid, topical and multiparticulates. The role involves ensuring compliance with USFDA, EU/Japan, ICH and DCGI guidelines, and preparing CMC documents for regulatory submissions.

You will develop manufacturing processes for R&D formulations, support tech transfer to large-scale batches, and work with QA, Regulatory Affairs, Analytical

Qualifications

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

Responsibilities

• Literature search for formulation development and regulatory considerations.

Skills

Literature search

Formulation & process development

Multi-formulation development across O

Analytical testing

Stability data evaluation

Tech transfer

CMC documentation

MS Word

MS Excel

PowerPoint

Education

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

Tools

MS Word

MS Excel

PowerPoint

Job description

1. Roles and Responsibilities:

• Responsible for literature search, formulation and process development of oral solid, Liquid, topical and multiparticulates.
• Basic understanding and knowledge of guidelines of stringent regulatory agency (USFDA, EU & Japan), ICH and DCGI.
• Good understanding and exposure of product development for screening and for optimization of formulation as well as process parameters.
• Design and manage formulation trials, analytical testing and evaluate stability data to finalize formulation composition.
• Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
• Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
• Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
• Execution of manufacturing of exhibit/submission batches per regulatory requirements.
• Support technology transfer for manufacturing processes from laboratory scale to production scale.
• Work with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products.
• Assure that all formulation and process development activities are documented in the lab notebook as per company procedures and GDP.
• Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.
• Actively participate in obtaining patents for products and processes.
• Good hands on MS word, excel and power point.

2. Educational qualifications/Experience

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