Process Development Principal Scientist

2 weeks ago

Singapore Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**

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 Principal Scientist **in **Amgen Singapore Manufacturing**.

**Process Development Principal Scientist**

**Live**:
**What you will do**

**Responsibilities**:

- Responsible for providing scientific and technical direction to support commercial production of biologic & chemical 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 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
- Supports and lead process, process safety and material risk assessment performed on-site
- Lead 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 responsibilities

**Win**:
**What we expect of you**:
**Qualifications**:

- Doctorate degree and 2 years of directly related experience OR
- Master’s degree and 6 years of directly related experience OR
- Bachelor’s degree and/or 8 years of directly related experience
- At least 8 years of relevant work experience in the commercial manufacturing environment within the biopharmaceutical industry
- At least 6 years’ experience with regulated environments (i.e. cGMP)
- Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
- Deep understanding of product quality attributes control strategies
- Expert knowledge of analytical methods/technologies used in biologics and synthetic manufacturing
- Expert understanding and hands-on experience of methods within the following platforms Chromatography, Bioassay, PCR,
- Immunoassay, CE, Gel, GC, MS, and Compendia supporting biologic and synthetic manufacturing
- Expert knowledge in setting up lab-based experiments and executing studies to support manufacturing
- Expert understanding and hands-on experience with method transfer and method validation processes with direct experience from a Pharmaceutical or Biotechnology Company.
- Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
- Strong working knowledge of regulatory expectations related to analytical control strategies
- Familiarity with applicable worldwide regulatory requirements
- Experience in authoring regulatory submissions.
- Experience collaborating and building solid working relationship 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 independently determine when additional resources are required to solve problems
- Ability to provide solutions to a large variety of technical problems

**Thrive**:
**What you can expect of us**

As we work to develop treatments that take care of others, so we work to care for our teammates’ 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

**for a career that defies

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