Senior Scientist - Analytical R&D

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Responsibilities:

• Independently lead analytical method develop and validation activities for assigned ANDA products.
• Develop and validate analytical methods for release and stability testing.
• Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
• Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.
• Resolve complex problems in method or product development.
• Develop and understand product stability to guide design of stability studies in support of product registration.
• Generate technical documents to support regulatory submissions.
• Provide timely analytical support on deficiency responses and product approval inspections.
• Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.
• Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.

Requirements:

• Peer review of lab notebooks.
• Evaluate, troubleshoot/improve existing analytical methods when necessary.
• Continuously update knowledge of latest technologies related to analytical science
• Work in compliance with cGMP/cGLP regulations.
• Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.
• Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.
• Strong knowledge of FDA, ICH, and USP guidance and regulations.