Analytical Method Development Trainee: GLP & QC Support

Lupin Ltd; Indiana; On-site; USD 65,000 - 100,000; Full time

Job summary

Lupin Ltd in Indiana is seeking an Analytical Chemistry professional to drive analytical method development for assay substances and dissolution by chromatographic methods. The role includes method validation, transfer, and the preparation of specifications and reports for drug products and excipients.

You will maintain GLP documents and environment, support regulatory queries, and assist site QC investigations to ensure compliance and high-quality results.

Qualifications

• Experience in analytical method development for assay-related substances and dissolution by chromatographic methods.
• Exposure to method validation and transfer processes.
• Preparation of specifications and standard test procedures; development reports for drugs and excipients.
• Maintenance and upkeep of GLP documents and GLP environment.

Responsibilities

• Develop analytical methods for assay-related substances and dissolution testing.
• Validate analytical methods and execute method transfers.
• Prepare specifications, standard test procedures, and development reports for drug products and excipients.
• Maintain GLP documentation and ensure GLP environment is upheld.
• Provide timely regulatory query support and assist site QC investigations.

Skills

Analytical Method Development

Method Validation

Method Transfer

GLP Compliance

Education

Masters in Analytical Chemistry or Pharmacy

Job description

Lupin Ltd in Indiana is seeking an Analytical Chemistry professional to drive analytical method development for assay substances and dissolution by chromatographic methods. The role includes method validation, transfer, and the preparation of specifications and reports for drug products and excipients.

You will maintain GLP documents and environment, support regulatory queries, and assist site QC investigations to ensure compliance and high-quality results.