Job Description

Job Summary:

We are seeking a Research Associate to join the Analytical Development team supporting the characterization and testing of complex biologics. This hands-on, on-site laboratory role involves the development, validation, and execution of analytical methods for drug substances and drug products across clinical and commercial phases. The ideal candidate will collaborate cross-functionally to provide analytical expertise for product development, process optimization, and regulatory support.

Responsibilities:

• Develop, validate, and execute analytical methods to support biologics development.
• Operate, maintain, and oversee installation of complex analytical instrumentation (e.g., LC/MS, CE-SDS).
• Author and review technical documents, including protocols, reports, SOPs, and change controls.
• Lead and contribute to scientific initiatives and technical projects.
• Collaborate with cross-functional teams including Process Development, R&D, and QC.
• Support laboratory operations including inventory management, reagent preparation, and documentation.
• Ensure compliance with applicable regulatory guidelines (ICH, GMP, GLP, GCP, GDP).

Qualifications:

• Master’s degree in biological sciences or related field with 5+ years, or PhD with 2+ years of industry experience (post-doc may be considered).
• Proficient in analytical techniques: absorbance assays, chromatography, LC/MS, CE-SDS, ELISA, western blot.
• Experience with characterization tools such as AUC, DLS, MFI, and CD.
• Skilled in drafting protocols, methods, and SOPs.
• Familiar with GxP practices and global regulatory requirements.
• Knowledge of statistical tools (e.g., R, Python) is preferred.
• Expertise in Liquid Chromatography and LC/MS.
• Background in neurotoxin therapeutics.

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