Job Description

Career Category Process DevelopmentLiveWhat you will doResponsibilities:

• Responsible for providing scientific and technical direction to support commercial production of biologic and synthetic drug substance
• Support new product introduction, troubleshooting and improvement of existing and new processes run at the Amgen Singapore Manufacturing site

• Assess initiatives associated to analytical method improvements and optimizations

• Responsible 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 improvements
• Responsible for planning detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
• Supports and/or lead cross-functional teams of experienced scientist and engineers through project challenges and implement advance scientific experiments, which contribute to the successful completion of goals and/or projects

• Responsible for experimentation in the lab to resolve technical issues observed during transfer / manufacturing at large scale

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilitiesWinWhat we expect of youQualifications

• Doctorate degree in Science, Engineering or related technological field OR
• Master\xe2\x80\x99s degree in Science, Engineering or related technological field and 2 years of directly related experience OR
• Bachelor\xe2\x80\x99s degree in Science, Engineering or related technological field and 4 years of directly related experience OR
• Diploma in Science, Engineering or related technological field and 8 years of directly related experience
• Good knowledge of state-of-the-art technologies, emerging scientific and regulatory directions for product attributes and testing.
• At least 6 years of relevant work experience in the commercial manufacturing environment within the biopharmaceutical industry is preferred
• At least 4 years\xe2\x80\x99 experience with regulated environments (i.e. cGMP) is preferred
• Experience in working closely with scientific, quality control and manufacturing disciplines across process development, clinical, and commercial operations
• Good understanding of product quality attribute and analytical control strategies and analytical methods/technologies used in biologics and synthetic manufacturing
• Good 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 impurities.
• Good understanding and hands-on experience with method qualification, transfer and validation processes with direct experience from a Pharmaceutical or Biotechnology Company.
• Experience and display knowledge in setting up laboratory-based experiments and executing studies to support manufacturing
• Familiarity with applicable worldwide regulatory requirements with working knowledge of regulatory expectations related to product quality attribute and analytical control strategies
• Experience in authoring regulatory submissions and responding to regulatory questions
• Experience in collaborating and building solid working relationship across departments, with diverse and remote staff and with external collaborators
• Display project management, planning and organizational skills
• Ability to independently uncover and resolve issues associated with the development and implementation of scientific projects
• Strong, interpersonal, written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
• 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

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.ThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates\xe2\x80\x99 professional and personal growth and well-being.

• 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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Amgen