Amgen Process Development Associate Scientist in Cambridge, Massachusetts

Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces, and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers ('BiTEs'), live oncolytic viruses, and synthetic medicines.

Responsibilities:

Develop, qualify and perform analytical methods for testing of late-stage clinical recombinant protein pharmaceuticals, including product characterization and comparability activities for - both drug substance and drug product.

Collaborate with other scientists in a multidisciplinary, multi-site team to execute the full scope of analytical methods for in-process testing, lot release, stability, comparability and protein structure characterization, while ensuring completion of notebook entries and reports.

Mass spectrometric method applications for product characterization, including primary structure / glycan structure elucidation, process characterization and product testing.

Data analyses and testing against acceptance criteria in support of process development, process/method transfers and comparability studies.

Provide regular updates, including writing of technical reports, and communication of project results as appropriate, including internal presentations and participating in national scientific meetings.

Keeping current with field of expertise, including literature and technology development.

Basic Qualifications

Master's degree & 2 years of Scientific experience

OR

Bachelor's degree & 4 years of Scientific experience

Preferred Qualifications

M.S. in biological sciences, biochemistry, physical sciences or chemical engineering

Expertise with mass spectrometry of proteins, peptides and glycans. Additional experience with analytical approaches such as Size-exclusion chromatography (SEC), Capillary Electrophoresis (CE) or Cation Exchange Chromatography CEX

3+ years of scientific experience within the biotech industry, experience to include data analyses, statistical analysis, setting acceptance criteria in support of process development, process/method transfers, and comparability studies

Good problem-solving skills utilizing the application of scientific theory

Ability to demonstrate skills in independently determining and developing scientific analysis and solutions, as well as demonstrate strong laboratory work skills to include the design and performance of scientific experiments and interpretation of results

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.