Analytical Development Lead

Key responsibilities

• Lead development of analytical methods for drug substances and drug products, including assay, related substances/impurities, dissolution, residual solvents, elemental impurities, nitrosamines and extractables/leachables.
• Plan, run and review method validation according to ICH Q2(R2), ICH Q14, USP and Ph. Eur. requirements.
• Manage analytical method transfers to QC laboratories, CMOs and manufacturing sites, including protocols, reports and troubleshooting.
• Provide analytical support to formulation development, including RLD characterization, comparative dissolution profiling, forced degradation and stability studies.
• Develop specifications and impurity control strategies in line with ICH Q3A/Q3B/Q3C/Q3D and M7.
• Prepare and review analytical sections of regulatory submissions (Module 3, CTD/eCTD) and respond to USFDA and EMA deficiency queries.
• Oversee instrument qualification, calibration and lab compliance with cGMP, GLP and data integrity (ALCOA+, 21 CFR Part 11).
• Lead, coach and develop a team of analytical scientists.
• Mentor and supervise Masters students under SanSphere’s university collaboration program, guiding their research projects, theses and analytical lab training.
• Work closely with Formulation, Regulatory Affairs, QA, QC and Manufacturing teams.

Qualifications and experience

• M.Pharm, M.Sc. or Ph.D. in Pharmaceutical Analysis, Analytical Chemistry, Chemistry or a related field.
• 10–15 years of analytical development experience in the pharmaceutical industry.
• Proven experience supporting ANDA and 505(b)(2) filings for USFDA and European markets.
• Strong hands-on experience in method development, validation and transfer for solid oral and injectable dosage forms.
• Expertise across analytical instruments, including HPLC/UPLC, ICP-MS, GC/GC-MS/headspace, LC-MS/MS, dissolution apparatus, UV-Vis, FTIR, KF titration, particle size analysis and other relevant techniques.
• Thorough knowledge of ICH, USP, Ph. Eur., USFDA and EMA guidelines.
• Experience in team leadership.

Preferred

• Experience mentoring or supervising Master’s or Ph.D. students, or working with academic and research institutions.
• Experience with nitrosamine risk assessment and trace-level analysis.
• Exposure to complex generics and injectable-specific testing (particulate matter, container closure integrity, E&L).
• Publications in analytical science.

Key skills
Analytical method development, method validation, method transfer, HPLC, UPLC, ICP-MS, GC, LC-MS, ICH Q2(R2), ANDA, 505(b)(2), USFDA, EMA, team leadership, mentoring