Job Title:
Analytical Scientist – DLT (Analytical R&D – OSD)
Job Summary
Dr. Reddy’s Laboratories is hiring an Analytical Scientist for its Analytical R&D – OSD division in Hyderabad. This role involves leading analytical method development, method validations, impurity evaluations, and ensuring compliance with global regulatory requirements, including China and Russia markets. The ideal candidate will possess deep expertise in analytical techniques, regulatory standards, and pharmaceutical R&D processes to support filings and market submissions in emerging regions.
Key Responsibilities
Evaluate lead country data and plan analytical activities to meet specific country regulatory needs.
Conduct method development and validation for various emerging markets (EM), especially China and Russia.
Plan and execute dissolution profile studies for EM filings.
Perform impurity evaluation studies for the Chinese market and update specifications (specs) and STPs for API, FP, and excipients as per China ChP compliance.
Provide technical support for OOS/OOT investigations and method transfer challenges at manufacturing sites.
Manage external CRO labs for peak workloads and oversee technical execution.
Address pre-filing regulatory queries and ensure closure of points before regulatory review.
Collaborate with cross-functional stakeholders including QA, QC, RA, and Product Development teams.
Review technical reports, method validation protocols, lab data, and ensure compliance with GLP and QMS standards.
Lead resolution of laboratory non-conformances and document corrective actions.
Required Skills & Qualifications
Master’s Degree in Chemistry or M. Pharm.
6–9 years of experience in analytical development, preferably in nutritional or pharmaceutical product portfolios.
Proficient in analytical chemistry, stability studies, impurity profiling, and advanced analytical techniques.
Familiarity with AOAC, BIS, and global regulatory bodies.
Strong understanding of GLP, SOPs, regulatory guidelines, and quality systems.
Skilled in MS Office tools – Word, Excel, PowerPoint.
Ability to manage third-party and CRO collaborations effectively.
Analytical problem-solving and risk assessment abilities.
Excellent verbal, written communication, and cross-functional coordination skills.
Team leadership and mentoring experience preferred.
Perks & Benefits
Competitive salary (as per industry standards).
Joining & relocation support.
Family support including maternity & paternity benefits.
Comprehensive medical and life insurance coverage.
Learning and development opportunities.
Exposure to international market filings and regulatory projects.
Company Description
Dr. Reddy’s Laboratories Ltd. is a globally recognized pharmaceutical leader with a presence in 66 countries. Known for delivering affordable and innovative medicines, Dr. Reddy’s focuses on cutting-edge research, sustainable practices, and regulatory excellence in the pharmaceutical industry.
Work Mode
On-site (Hyderabad, India)
Salary/Compensation
Not disclosed in the job description.
Call to Action
Ready to advance your pharmaceutical analytical career with Dr. Reddy’s Laboratories? Apply now and contribute to global regulatory success and analytical excellence.
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