Amgen Process Development Scientist - Protocol and Report Writing in Cambridge, Massachusetts
Amgen is a biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Amgen's Attribute Sciences group within Process Development is seeking a Scientist. The Process Development Scientist will be responsible for the strategy, execution, analysis and communication of method transfer and method validation protocol and report writing. This candidate will help to drive improving this process and effectively communicate results with internal and external partners across a global network.
The Scientist role in Commercial Process Development will be part of a team responsible for authoring method transfer and method validation protocols and reports for clinical/commercial programs for the following method platforms: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocols and reports will be authored according to regulatory and industry guidelines (i.e., ICH). This individual will support clinical and commercial locations throughout the company. This position works closely with representatives from key functions within Process Development, Manufacturing and Quality.
OR Master's degree and 4 years of Operations or Scientific experience
OR Bachelor's degree and 6 years of Operations or Scientific experience
PhD in Biochemistry, Analytical Chemistry, Physical or Life Sciences
Strong understanding and hands-on experience of methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General
Strong understanding and hands-on experience with method transfer and method validation processes with direct experience from a Pharmaceutical or Biotechnology Company.
Advanced knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing
Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
Demonstrated ability to critically analyze and interrogate various analytical data sets to drive and influence the process
Demonstrated ability to propose and drive new scientific initiatives
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.