Process Development Senior Engineer
1 week ago
## **Career Category**Process Development## ## **Job Description****Process Development Senior Engineer****Amgen Singapore Manufacturing**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 Engineer in Amgen Singapore Manufacturing.****Live****What you will do*** Assume a Subject Matter Expert role within ASM Process Development for cell culture and/or purification commercial process support.* Act as Drug Substance Team Leader within the global Product Development Team (PDT); providing stewardship of product lifecycle and process improvement. This is a global role that interacts with other experts in the areas of Drug Product, Regulatory Affairs, Quality, Business Operations, Supply Chain, and Attributes Sciences.* Lead complicated investigations independently, providing concise communications to teams and leadership* Integrate trends, data and information into plans, deliverables and recommendations* Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.* lead productivity projects, process optimization, and product life cycle management.* Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.* Apply best practices to leverage data for more proactive and predictive approaches.* Support regulatory filings, audits and inspection, and other CMC activities (e.g author and review regulatory submissions and responses to questions as required).* 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****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* 6+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries* At least 4 years' experience with regulated environments (i.e. cGMP) required* In depth cell culture and/or purification process knowledge, including single-use technologies and harvest technologies* Good understanding of process characterization and process scale up to resolve technical issues observed during
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Singapore Amgen Full time**Process Development Senior Engineer** **Amgen Singapore Manufacturing, Singapore** **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...
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Process Development Senior Engineer
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Singapore Amgen Full time $120,000 - $180,000 per yearCareer CategoryEngineeringJob DescriptionProcess Development Senior Engineer Amgen Singapore ManufacturingHOW 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...
