Process Development Scientist Full-time

Process Development Scientist

Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Process Development Scientist in Amgen Singapore Manufacturing.

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.

Role Description:

• The 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 also 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.

Basic Qualifications:

• 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 you can expect of us:

• 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

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.

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.