Process Development Scentist

2 weeks ago

Tuas, Singapore Amgen Full time

Career Category

Process Development

**Job Description**:
Role Description:

- 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.

Education / Licenses
- Advanced degree in Engineering, Chemistry, 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

Relevant 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.

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 support and provide solutions to technical problems

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