Amgen Process Development Principal Scientist Pivotal Attribute Sciences in Cambridge, Massachusetts
Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.
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 Principal Scientist, the candidate will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes, as well as providing mentorship to junior ASTL's and technical guidance to analytical teams performing Marketing Application - enabling product characterization.
This position is located in our Cambridge, MA office.
Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development
Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
Develop and lead teams that define the attribute criticality and the quality target product profile (QTPP) for pivotal candidate therapies
Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications
Doctorate degree and 3 years of Scientific experience
Master's degree and 6 years of Scientific experience
Bachelor's degree and 8 years of Scientific experience
Strong scientific background in biologics method development and product characterization
PHD in Biochemistry
3+ years' experience in industrial analytical laboratories supporting method development and testing of commercial or clinical protein products
Demonstrated proficiency in: solving complex problems, ability to work independently, proactively seeking outside resources and collaboration
A self-starter and team player with strong leadership and decision-making skills, who can provide mentorship to junior staff
Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects
Someone who strongly values working on and leading 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.