Process Development Senior Associate
2 weeks ago
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 Senior Associate in Amgen Singapore Manufacturing.
What you will do
- Responsible for providing scientific and technical support for commercial production and testing 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 with 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 procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
- Supports cross-functional teams of scientists and engineers through project challenges and implements 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/testing and manufacturing at large and laboratory scales
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
What we expect of you
Qualification
- Master’s degree in Science, Engineering or related technological field
- Bachelor's Degree in Science, Engineering or related technological field and 2 years of directly related experience OR
- Associate degree in Science, Engineering or related technological field and 6 years of directly related experience OR
- Diploma in Science, Engineering or related technological field and 8 years of directly related experience
- Good knowledge of innovative technologies, emerging scientific and regulatory directions for product attributes and testing
- Display basic knowledge of the manufacturing practices, regulatory requirements, scientific properties and risks associated with biologic and synthetic drug processing
- Experience in working closely with scientific, quality control and manufacturing disciplines across clinical and commercial operations
- Good understanding of product quality attributes, analytical control strategies and analytical methods/technologies used in biologic and synthetic manufacturing
- Good understanding and hands-on experience with qualification, transfer and validation of methods (chromatography, capillary electrophoresis, PCR, immunoassay, etc.) used in release, in-process and stability testing to analyze or to characterize drug substance, product variants and process related impurities
- Experience and display knowledge in setting up laboratory-based experiments and executing studies to support manufacturing
- Experience in collaborating and building solid working relationships 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 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.
What you can expect of usAs 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity StatementAmgen 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.
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