Amgen Process Development - Scientist in Singapore, Singapore
This Scientist position will be a Synthetic Chemistry subject matter expert. The role will be responsible for providing scientific and technical direction to support commercial production of chemical synthetic drug substance
This role will support new product introduction, troubleshooting and improvement of existing and new API (synthetic molecule) processes run at the Amgen Singapore Manufacturing site. The role will assess initiatives associated to process improvements and optimizations
This individual will be responsible for the development and preparation of laboratory-based experiments to support small scale model interrogation, investigations, and process improvements. The individual will be also responsible for planning detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
The role supports and/or leads cross-functional teams of experienced scientists and engineers through project challenges and implement advance scientific experiments, which contribute to the successful completion of goals and/or projects
This individual will support and/or lead process, process safety and material risk assessment performed on-site.
Education / Licenses
Advanced degree in Engineering, Life 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
Strong knowledge of state of the art technologies and emerging scientific and regulatory directions for API processing is required.
At least 6 years of relevant work experience in the commercial manufacturing environment within the biopharmaceutical industry is preferred.
At least 4 years experience with regulated environments (i.e. cGMP, OSHA, EPA) is preferred.
Competencies / Skills
Extensive knowledge of the manufacturing practices, regulatory requirements, scientific properties and risks associated with synthetic processing.
Knowledge of different synthetic API processing platfoms (i.e. reaction, concentration, crystallization, isolation, drying)
Experience in the development and qualification of methods used in release, in-process, and stability testing to analyze or to characterize synthetic molecule and product variants, and process-related impurities (e.g., HPLC, UPLC, mass spectrometry)
Setting up and running synthetic molecule laboratory based experiment
Experience collaborating with experience networking and building solid working relationships across departments, with diverse and remote staff and with external collaborators.
Team leadership, management, and facilitation skills.
Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects.
Strong communication skills (technical writing and verbal communication/presentation)
Familiarity with documentation in a highly regulated environment
Ability to independently determine when additional resources are required to solve problems
Ability to provide solutions to a large variety of technical problems