Amgen

Process Development Scientist

Employer
Amgen
Location
Cambridge, MA, US
Posted
Jun 07, 2019
Ref
R-77812
Required Education
Doctorate/PHD/MD
Position Type
Full time
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

We are seeking a Process Development Scientist in 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. We are seeking someone who is well-recognized in the scientific community through a sustained record of peer-reviewed publications and patents.

The Process Development Scientist will report to the Process Development Senior Scientist in an integrated 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 unique opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to biospecifics and siRNAs.

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.

Job Responsibilities include:
  • Apply established platform approaches and utilize solid problem-solving skills to rapidly solve drug substance challenges and build robust processes with efficient experimentation
  • Drive new approaches and utilize out-of-the-box thinking to contribute to technology development
  • Demonstrate the desire to expand and develop skills in cell culture and purification, 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 deliverables of drug substance in a cGMP manufacturing environment
  • Execute projects as part of a team
  • Demonstrate collaborative experience and ability to effectively work through others
  • Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing
  • Give presentations within the department and to senior management with minimal supervision
  • Create, generate, and present paper/presentations at scientific meetings


Basic Qualifications

Doctorate degree

OR

Master's degree & 4 years of scientific experience

OR

Bachelor's degree & 6 years of scientific experience

Preferred Qualifications
  • Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences
  • Proven track record problem solving and trouble-shooting protein drug substance process including purification processes, bioreactor process development, cell line development or high throughput screening (HTS) technologies, 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 (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 progressively increased scope and a demonstrated ability to inspire 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 diverse 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


Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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