Analytical Development Chemist

1d1 day ago

Sanofi

AU · Full-time · A$110,000 – A$140,000

About this role

Opella seeks an experienced Analytical Development Chemist to join the Analytical Development team at our Virginia site. You will plan and conduct professional scientific testing while developing and validating test methods using various instruments and techniques. This role supports our mission to make self-care simple for half a billion consumers worldwide.

Daily tasks include researching, developing, and validating stability-indicating analytical methods utilising HPLC, UHPLC with LC-MS, GC-FID, dissolution testing, HPTLC, and ICP-MS/OES. You will conduct validations for dosage forms like raw materials, tablets, capsules, and liquids. Execute in-house stability testing of actives ensuring Right First Time standards.

Review fellow staff work for precision and accuracy against test methods and SOPs. Prepare protocols, test methods, and reports while reporting OOS/OOT results and executing CAPAs. Comply with GMP, GLP, pharmacopoeia, and occupational health procedures in all practices.

Perform instrument calibration, maintenance, and troubleshooting. Provide training, oversee method transfers to QC, and participate in cross-team troubleshooting. Join our 11,000-strong global team as a B Corp advancing healthier people and planet.

Requirements

Experience planning and conducting professional scientific testing in analytical development
Proficiency developing and validating test methods using HPLC, UHPLC, LC-MS, GC-FID
Skills in dissolution testing, HPTLC, ICP-MS, and ICP-OES
Knowledge of analytical method validation for various dosage forms
Ability to execute stability-indicating assays and evaluate raw materials
Familiarity with OOS/OOT investigations and CAPA execution
Understanding of GMP, GLP, pharmacopoeia, and SOP compliance
Competence in instrument calibration, maintenance, and troubleshooting

Responsibilities

Research, develop, and validate stability-indicating analytical test methods using HPLC, UHPLC with LC-MS, GC-FID, dissolution testing, HPTLC, ICP-MS/OES
Conduct analytical method validations for dosage forms including raw materials, tablets, two-piece capsules, softgel capsules, liquids
Execute in-house testing of actives using stability-indicating methods during stability programs ensuring Right First Time standards
Evaluate suitability of new raw materials
Check fellow staff members’ work for precision and accuracy against test methods and SOPs
Prepare key quality documentation including protocols, test methods, and reports
Report OOS/OOT results, participate in laboratory investigations, and execute CAPAs
Perform calibration, maintenance, and troubleshooting of laboratory instruments