Dr.Reddy's
Designation : Scientist
Function : AR&D
Functional Area : Analytical Development - Parenterals
Job Role Summary : Developing and validating analytical methods for injectable products, conducting literature reviews
Job Profile :
- You will be responsible Analytical method development and validation of injectable products.Â
- You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field.
- You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department.
- You will be responsible to execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team.Â
- You will be responsible for analytical method development for drug products for various tests mentioned in the specification in order to analyse the product development batches for the prototype screening.Â
- You will be responsible for analytical method validation activities at the manufacturing sites providing method development reports to verify the validation parameters and ensure the execution of method validation as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing.Â
- You will be responsible for analytical method transfer to plant locations successfully in order to train the Quality Control (QC) team on the methods for the Exhibit and commercial batch analysis at plant.
- You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results.
- You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy.
- You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions.
- You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements.Â
Job Requirements :
- 6-12 years of experience in analytical method development
- Extensive work experience in analytical method development and validation of injectable products.
- Proven experience with injectable, ophthalmic, peptide, and suspension products.
- Demonstrated expertise in sameness and characterization studies for complex molecules.
- Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.
- Advanced skills in troubleshooting analytical methods and instruments.
- Comprehensive understanding of Abbreviated New Drug Application (ANDA) filing requirements.
- Strong knowledge of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
- Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.
- Familiarity with Quality by Design (QbD) principles and their application in analytical method development.
- Experience with stability testing and forced degradation studies for injectable products.
- Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.
Work / Job Experience : 6-12 Years
Type of Experience : Analytical development, injectables
Academic Qualifications :
- Masters in Science/ Organic chemistry/ Pharmaceutical Sciences
