Process Development Scientist

Amgen

Amgen is seeking a Process Development 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 purification processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. 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 bispecifics 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.

Basic Qualifications

Doctorate degree

OR Master’s degree & 4 years of scientific experience

OR Bachelor’s degree & 6 years of scientific experience

Key Activities for the Process Development Scientist include:

o Apply established platform approaches and utilize solid problem-solving skills to rapidly solve

purification challenges and build robust processes with efficient experimentation

o Drive new approaches and utilize out-of-the-box thinking to contribute to technology

development

o Demonstrate the desire to expand and develop skills in cell culture, thereby further contributing to the integrated group

o 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.

o Deliver process amenable to cGMP operation and carry out deliverables of drug substance in a cGMP manufacturing environment

o Apply team experience to facilitate cohesiveness and build team spirit

o Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing

o Give presentations within the department and to senior management with minimal supervision

o Actively create, generate, and present paper/presentations at scientific meetings

Preferred Qualifications

o Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences

o Proven track record problem solving and trouble-shooting protein purification processes,

preferably in a process development environment

o Strong understanding and extensive hands-on experience in protein chromatography, including

affinity, ion exchange, and hydrophobic interaction chromatography

o Experience in filtration operations, including ultrafiltration/diafiltration (UF/DF)

o Demonstrated ability to independently identify, develop and implement scientific solutions to

practical problems.

o Motivated self-starter with excellent interpersonal and organizational skills

o 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

o Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications

o Excellent verbal communication and scientific writing skills

o Demonstrated success working with diverse team members in a dynamic, cross-functional

environment

o Familiarity with design of experiments and statistical analysis of data

o Knowledge of license application and the drug development process

o 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.

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Type

Mid-level industry position

North%20America%2C%20Cambridge%2C%20United%20States

North America

Cambridge , United States

Location

United States

Cambridge

Type

Mid-level industry position

North%20America%2C%20Cambridge%2C%20United%20States