Analytical R&D Lead JB-31

We are seeking an experienced Analytical R&D Lead to join our new Analytical R&D group. The successful candidate will be responsible for developing, validating, and implementing state-of-the-art analytical methods to support R&D, process development, and regulatory submissions.

Key Responsibilities:

• Lead new and ongoing projects in the Analytical R&D group
• Develop and implement an analytical strategy aligned with company goals
• Collaborate with cross-functional teams to support pipeline development
• Design, develop, and validate analytical methods for characterization, stability studies, impurity profiling and release testing
• Implement advanced techniques such as HPLC/UPLC, LC-MS, GC, ELISA, and spectroscopy
• Ensure compliance with ICH, FDA, EMA, and GMP/GLP regulatory guidelines and support writing the analytical section of IND, NDA, BLA regulatory submissions
• Establish and maintain Standard Operating Procedures (SOPs) and data integrity protocols (21 CFR Part 11 compliance)
• Support tech transfer from R&D to QC

Education & Experience:

• Ph.D. in Biotechnology, Biochemistry, Pharmaceutical Sciences, or related field (or MS with 8+ years of experience)
• More than 3 years industry experience in Analytical R&D
• Prior experience in leading analytical teams/projects – advantage

Skills:

• Expertise in chromatography (HPLC, UPLC, GC), mass spectrometry (LC-MS, GC-MS), spectroscopy (UV-Vis,), electrophoresis (CE, SDS-PAGE), and bioassays (ELISA, qPCR)
• Experience in method development, validation and troubleshooting
• Strong understanding of regulatory requirements (ICH, FDA, EMA, GMP, GLP, USP, EP) - advantage
• Knowledge of LIMS, electronic lab notebooks (ELN) and data integrity principles – advantage
• Excellent written and verbal English communication skills, with a proven ability to write clear, concise reports, regulatory submissions and scientific publications
• Strong analytical and problem-solving abilities
• Effective communication and cross-functional collaboration skills