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The Process Development Scientist at Amgen leads in the design, development, and optimization of manufacturing processes. They apply their scientific expertise to increase efficiency, improve product quality, and address manufacturing challenges, while maintaining adherence to regulatory standards.
Job Responsibility:
Lead in the design, development, and optimization of manufacturing processes
Apply scientific expertise to increase efficiency, improve product quality, and address manufacturing challenges, while maintaining adherence to regulatory standards
Be a Synthetic Chemistry subject matter expert
Provide scientific and technical direction to support commercial production of chemical synthetic drug substance
Support new product introduction, troubleshooting and improvement of existing and new API (synthetic molecule) processes
Assess initiatives associated to process improvements and optimizations
Develop and prepare laboratory-based experiments to support small scale model interrogation, investigations, and process improvements
Plan detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
Support and/or lead cross-functional teams of experienced scientists and engineers through project challenges and implement advance scientific experiments
Support and/or lead process, process safety and material risk assessment performed on-site
Requirements:
Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
Strong knowledge of 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) is preferred
Extensive knowledge of the manufacturing practices, regulatory requirements, scientific properties and risks associated with synthetic processing
Knowledge of different synthetic API processing platforms (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 support and provide solutions to technical problems
What we offer:
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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