Amgen Process Development Senior Associate - Pivotal Attribute Sciences 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.
As a PD Senior Associate, the successful candidate will participate in protein characterization studies to support regulatory filings using state of the art separation techniques and mass spectrometry (MS). The candidate will also work to develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods. They will interface with other process development departments to support commercial process development and process characterization studies in support of marketing applications.
This position is located in our Cambridge, MA office.
Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms
Perform peptide mapping, intact mass, and other LC-MS studies to support product characterization and comparability studies
Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods
Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment
With a focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions
Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways
Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications Basic Qualifications Master's degreeORBachelor's degree and 2 years of Scientific experience Preferred Qualifications
Scientific background in method development and product characterization for therapeutic proteins
Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects
A self-starter, and someone who values working in teams
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.