Process Development Senior Scientist

Career Category Operations Job Description

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Let's do this. Let's change the world. In this vital role you will be responsible for development, characterization, scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and dynamic pipeline.

With Amgen's biology first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and siRNAs. The Pivotal Drug Substance Process Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across the Amgen portfolio. Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation Drive innovation and utilize out-of-the-box thinking to contribute to technology development Expand and develop skills in purification and cell culture, thereby further contributing to the integrated group Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner.

Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing

• Basic Qualifications:
  
  Doctorate degree OR Master's degree and 2 years of Life Sciences experience OR Bachelor's degree and 4 years of Life Sciences experience
• Preferred Qualifications:
  
  Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
• Consistent track record of decision-making and trouble-shooting protein drug substance purification processes, preferably in a process development environment
• Strong understanding and extensive hands-on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography
• Experience in filtration operations, including ultrafiltration/diafiltration
• Understanding of protein characteristics and critical attributes to direct product/process control strategies
• Proven ability to independently identify, develop and implement scientific solutions to practical problems.
• Motivated self-starter with excellent interpersonal and organizational skills
• Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists
• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications
• Demonstrated success working with diverse team members in a dynamic, cross-functional…