Analytical Specialist- Formulation AR&D

Job Description

• Analyze critical API, excipient, and FP methods in R&D, and prepare verification reports to facilitate method transfer at the manufacturing site.
• Core knowledge on Derma products, method development, and technology transfer is mandatory.
• Perform elemental, genotoxic, and nitrosamine impurity assessments.
• Develop and validate residue analytical methods.
• Prepare technical justification reports in consultation with an expert.
• Execute experiments to finalize critical methods and prepare method design and development reports.
• Identify and ensure the availability of prerequisites like columns, chemicals, impurities, and standards for AMT at partner sites
• Prepare specification, STPs, Justification and technical reports for the assigned products
• Understand regulatory requirements specific to all regulated markets.
• Knowledge on drafting the responses to regulatory queries.
• Conversant with all pharmacopeias and guidelines.
• Identify new technologies for project-specific challenges

Additional Information

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.