Amgen-posted 3 months ago
$112,977 - $139,179/Yr
5,001-10,000 employees

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

  • Communicate and interface between the GMP manufacturing teams and Process Development scientific groups.
  • Have ownership and oversight of Single Use Systems technology for the Manufacturing area.
  • Generate training materials and provide training on scientific or technical aspects of the Single Use Systems.
  • Create, review, and approve Standard Operating Procedures (SOP).
  • Develop, manage, and run change controls associated to area of expertise.
  • Complete deviation investigations along with corresponding preventive/corrective action records.
  • Apply process, quality, compliance, and analytical knowledge to keep the manufacturing area operational.
  • Provide technical support and subject matter expertise for Single Use Systems.
  • Oversee and support ongoing development of all manufacturing systems related to Single Use Systems.
  • Train staff on Single Use systems.
  • Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification.
  • Facilitate process, area, and equipment risk assessments.
  • Engage in regulatory inspections and in the NPI process.
  • High school diploma / GED & 10 years of biotechnology operations experience OR Associate’s degree & 8 years of biotechnology operations experience OR Bachelor’s degree and 4 years of biotechnology operations experience OR Master’s degree in chemistry, biology or engineering and 2 years of biotechnology operations experience OR Doctorate degree.
  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills.
  • Experience in GMP manufacturing operations.
  • Ability to effectively communicate complex technical information.
  • Ability to coach, mentor and/or cross train colleagues.
  • Background in lean manufacturing methodologies and operational excellence.
  • Strong technical knowledge of Single Use System use at a drug substance company.
  • Proficient technical writing and presentation skills.
  • Experience in supporting regulatory submissions and inspections.
  • Competitive and comprehensive Total Rewards Plans aligned with local industry standards.
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