What you will doResponsibilities:Responsible for providing scientific and technical direction to support commercial production of biologic and synthetic drug substanceSupport new product introduction, troubleshooting and improvement of existing and new processes run at the Amgen Singapore Manufacturing siteAssess initiatives associated with analytical method improvements and optimizationsResponsible for the development and preparation of laboratory-based experiments to support method transfers, qualifications & validations, analytical support to small scale model interrogation, investigations, and process improvementsResponsible for planning detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resourcesSupports and/or leads cross-functional teams of experienced scientists and engineers through project challenges and implements advanced scientific experiments, which contribute to the successful completion of goals and/or projectsResponsible for experimentation in the lab to resolve technical issues observed during transfer / manufacturing at a large scaleAll listed tasks and responsibilities are deemed as essential functions of this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilitiesWhat we expect of youQualificationsDoctorate degree in Science, Engineering, or related technological field ORMaster's degree in Science, Engineering, or related technological field and 2 years of directly related experience ORBachelor's degree in Science, Engineering, or related technological field and 4 years of directly related experience ORDiploma in Science, Engineering, or related technological field and 8 years of directly related experienceGood knowledge of state-of-the-art technologies, emerging scientific and regulatory directions for product attributes and testingAt least 6 years of relevant work experience in the commercial manufacturing environment within the biopharmaceutical industry is preferredAt least 4 years' experience with regulated environments (i.e. cGMP) is preferredExperience in working closely with scientific, quality control, and manufacturing disciplines across process development, clinical, and commercial operationsGood understanding of product quality attribute and analytical control strategies and analytical methods/technologies used in biologics and synthetic manufacturingGood understanding and hands-on experience of methods within the platforms Chromatography, PCR, Immunoassay, capillary electrophoresis, mass spectrometry, and compendia supporting biologic and synthetic in-process, release, and stability testing to analyze or to characterize drug substance, product variants, and process-related impuritiesGood understanding and hands-on experience with method qualification, transfer, and validation processes with direct experience from a Pharmaceutical or Biotechnology CompanyExperience and display knowledge in setting up laboratory-based experiments and executing studies to support manufacturingFamiliarity with applicable worldwide regulatory requirements with working knowledge of regulatory expectations related to product quality attribute and analytical control strategiesExperience in authoring regulatory submissions and responding to regulatory questionsExperience in collaborating and building solid working relationships across departments, with diverse and remote staff and with external collaboratorsDisplay project management, planning, and organizational skillsAbility to independently uncover and resolve issues associated with the development and implementation of scientific projectsStrong interpersonal, written, and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environmentFamiliarity with documentation in a highly regulated environmentAbility to independently determine when additional resources are required to solve problemsAbility to provide solutions to a large variety of technical problems
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