Amgen Scientist in Singapore, Singapore
Amgen is a biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Amgen's Attribute Sciences group within Product Development is seeking a Scientist for a position based at their Singapore manufacturing site. This role is in the Commercial Attribute Sciences group and will be a technical and laboratory-based contributor for Amgen's commercial Biological and Synthetic Product assets. The Scientist will run analytical methods and contribute to analytical filings. The Scientist will also provide technical support for analytical methods run in quality control laboratories, methods run on the manufacturing floor, and online process analytical technologies connected to pharmaceutical processing systems. This role will be a point of contact for troubleshooting and method performance, and participate in the writing of responses to health authority questions over the commercial lifecycle of Amgen's products.
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).