Process Development Sr. Scientist

Career Category

Process Development

Job Description

Amgen is seeking a Process Development Senior Scientist (Cambridge, MA) to join the Pivotal Bioprocesses Sciences & Technologies group within the Pivotal Drug Substance Process Development organization. The Process Development Scientist 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. This will require developing expertise in bioprocess purification and/or cell culture processing.

The Process Development Scientist will work in an integrated group in which cell culture and purification scientists work together to advance Amgen's rich, exciting and multifaceted 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.

The Pivotal Drug Substance Process Development organization at Amgen develops, characterizes and supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.

Responsibilities:

• Lead an integrated group of cell-culture and purification scientists working in combined teams to advance Amgen's dynamic pipeline.
• Develop strong teams and support staff in career development.
• Apply established platform approaches and utilize validated problem-solving skills to rapidly seek drug substance challenges and build robust processes with efficient experimentation
• Drive new approaches and utilize out-of-the-box thinking to supply to technology development
• 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 deliverables of drug substance in a cGMP manufacturing environment
• Ability to execute projects leading a team of junior scientist
• Proven reciprocal experience and ability to efficiently work through others
• Author, or provide direction for the authorship of, technical report or CMC regulatory submissions
• Give presentations within the department and to senior management with minimal supervision
• Actively build, generate, and present paper/presentations at scientific meetings
• Well-recognized in the scientific community through a sustained record of peer-reviewed publications and patents

Basic Qualifications

Doctorate degree and 2 years of scientific experience
OR
Master's degree and 5 years of scientific experience
OR
Bachelor's degree and 8 years of scientific experience

Preferred Qualifications

• Doctorate in biological science discipline or chemical engineering with 5+ years of experience
• Extensive experience in development and/or support of commercial manufacturing processes, including process scale-up
• Experience in CMC commercialization process
• Leadership of a lab group or leadership experience of functional or cross-functional project
  teams and demonstrated results from leadership opportunities
• Track record of innovation and implementation of new technologies
• Experience in authoring BLA sections and interaction with regulatory agencies
• Proven record problem solving and trouble-shooting protein drug substance process including purification processes, bioreactor process development, or high efficiency screening (HTS) technologies, preferably in a process development environment
• Strong understanding in protein chromatography in chromatography
• Experience in filtration operations, including ultrafiltration/diafiltration (UF/DF)
• Scientific understanding of current bioreactor technologies, as well as the ability to explore and develop new approaches to further advance innovative bioreactor technologies
• Understanding of protein characteristics and critical attributes to direct bioreactor development and product/process control strategies
• Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems
• Motivated self-starter with excellent interpersonal and organizational skills
• Leadership experience of dynamically increased scope and a demonstrated ability to encourage and lead a group of scientists to deliver on complex and challenging objectives in defined timelines
• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications
• Excellent verbal communication and scientific writing skills
• Demonstrated success working with complementary team members in a dynamic, cross-functional environment
• Familiarity with design of experiments and statistical analysis of data
• Knowledge of license application and the drug development process
• Exposure to cGMP manufacturing and CMC components of regulatory submissions

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.