This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
Responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations
Use engineering principles to implement manufacturing process in a cGMP environment
Provide solutions to a variety of technical problems of moderate scope and complexity to enable Technology Transfer of various clinical and commercial molecules
Under general supervision will evaluate, select and apply standard engineering techniques and procedures
Perform assignments that have clear and specific objectives and require investigation of limited number of variables
Initiate and complete routine technical tasks associated with Technology Transfer
Routinely monitor manufacturing processes for performance indicators and operations
Suggest problem resolution and provide troubleshooting mentorship
Apply engineering principles and statistical analysis, including design of experiments, in-order to address processing issues and evaluate opportunities for process improvements
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications
Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments
Support non-standard shift organization and extended hours, as per business needs
Up to 15% travel is possible - domestic and international
Requirements:
High school diploma / GED and 8 years of Engineering or Operations experience
Associate’s degree and 6 years of Engineering or Operations experience
Bachelor’s degree and 2 years of Engineering or Operations experience
Master’s degree
Nice to have:
Education background in Chemical Engineering, Bioengineering or Biotechnology
2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes
Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
Experience working with commercial manufacturer of biologics using single use technology
Basic understanding cGMP requirements
Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP)
Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, MMA, CEX, Viral Filtration, UFDF, and sterile filtration among others for a variety of biological molecules
Experience working with data and digital tools preferred
Proficient re: the analysis of data generated from an array of analytical techniques
Regulatory knowledge and interactions and project management skills
Strong oral and verbal communication and presentation skills
Fluency in foreign languages preferred
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan