Singapore – Singapore
• Execute laboratory-based experiments in conjunction with drug substance colleagues to support small-scale model interrogation, investigations, and process improvements
• Represents Attribute Sciences on site-based teams and develops effective partnerships with partners from analytical development groups world-wide, Regulatory partners, Quality Control and Assurance groups, and Manufacturing.
• Provides technical guidance and input for analytical activities for commercial programs.
• Applies expertise in attribute assessment tools to optimize and improve analytical deliverables over the commercial lifecycle of a product.
Education / Licenses
• Advanced degree in Engineering, Science or related technological field
• Doctorate degree & 1 year of directly related experience OR
• Master’s degree & 4 years of directly related experience OR
• Bachelor’s degree & 6 years of directly related experience
• 6+ years of relevant work within the biotechnology or pharmaceutical industries.
• At least 4 years experience with regulated environments (i.e. cGMP, OSHA, EPA) required.
Competencies / Skills
• Excellent communication and organizational skills as well as the ability to work in a strong team environment.
• Experience in the development and qualification of methods used in release, in-process, and stability testing to analyze or to characterize monoclonal antibodies and other recombinant protein therapeutics, product variants, and process-related impurities (e.g., HPLC, UPLC, electrophoresis, mass spectrometry)
• Familiarity with techniques for higher order structure (e.g., CD, DSC, FTIR) and bioanalytical characterization (e.g., Biacore, cell based assays)
• Demonstrated expertise in analytical troubleshooting and problem solving.
• Comprehensive knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings.
• Prior experience supporting technology transfer and commercial quality and manufacturing operations
• Familiarity with Laboratory Information Management System (LIMS).
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