💼 Job Title: Research Scientist – AD-ARPL-ARDT AR
🏢 Company: Apotex
📍 Location: Bangalore, Karnataka
🧑🎓 Experience:
- BSc – 5 years in pharmaceutical R&D lab
- MSc – 3–4 years in pharmaceutical R&D lab
🎓 Education: Graduate/Postgraduate in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field
🌐 Website: Apotex
📝 Job Description:
🔹 Summary:
- Plan and execute analytical method development and validation for new products
- Conduct comprehensive testing of API and finished dosages following regulatory, compliance & safety requirements
- Review laboratory data, instrument logs, and reports
- Manage departmental Change Control Requests (CCR) via QMS
- Prepare Transfer of Analytical Procedures (TAP) protocols and reports
- Handle regulatory documentation like SOPs, protocols, and reports
🔹 Responsibilities:
- Develop stability-indicative analytical methods for drug substances & finished products
- Execute protocol preparation, planning, review, and reporting for analytical validation
- Perform analytical tests on API, PE/PO samples, and dosage submissions (assay, degradation products, dissolution, physical testing)
- Conduct lab investigations for OOS/OOT results
- Initiate, execute, and complete technology transfer and collaborative validation activities
- Maintain instruments and departmental quality systems
- Participate in cGMP trainings, team collaboration, and ensure regulatory & safety compliance
🔹 Skills & Knowledge Required:
- HPLC, GC, spectrophotometer, dissolution apparatus, wet chemistry techniques
- HPLC method development and validation
- Document preparation & review (SOPs, protocols, reports, deviations)
- Knowledge of cGMP, regulatory guidelines, and troubleshooting analytical instruments
- Familiarity with LIMS is a plus
- Strong written & verbal English communication skills
🏢 About Apotex:
Apotex is a Canadian-based global health company providing affordable, innovative medicines worldwide. Headquartered in Toronto, with regional offices globally, Apotex is the largest Canadian-based pharmaceutical company.
🚀 How to Apply:
🏷️ Tags: Apotex Jobs, Chemistry Jobs, Scientist Jobs
