Amgen Process Development Senior 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 modalities, and synthetic medicines.
There are two exciting career opportunities to join the Pivotal Attribute Sciences teams based in Amgen Cambridge, Massachusetts site. In these roles you will support development of late stage development biological therapeutic products as analytical team leader representing Attribute Sciences in cross-functional product delivery team.
These two roles include:
Determining clinical product critical quality attributes through risk assessment, and defining the product quality target product profile to define process development.
Defining the analytical target profile for the methods used to monitor product quality. Provide expertise for continuous development of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
Oversee the development and characterization of all methods used to test the product, with functional focus in separation sciences and mass spectrometry.
Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification. Interpret results, author technical protocols, reports, analytical method descriptions and analytical Chemistry, Manufacturing & Controls (CMC) sections in regulatory documents.
Lead program-oriented Attribute Sciences matrix analytical team and ensuring that project deliverables are appropriately planned, executed and communicated to cross-functional partners. Represent the Attribute Sciences department at product delivery team meetings.
Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.
Answer analytical and product quality questions from health authorities, participate in regulatory inspections and regulatory meetings.
Supervising or mentoring junior staff
Doctorate degree and 2 years scientific experience
Master's degree and 5 years of scientific experience
Bachelor's degree and 7 years of scientific experience
PhD in Biochemistry
Ability to lead transversal project teams, as well as previous managerial experience
Strong scientific background in biologics method development and product characterization
Demonstrated proficiency in solving complex problems, ability to work independently and proactively seek collaboration, a self-starter and team player with strong leadership and decision-making skills
Supervisory experience with a demonstrated proficiency in providing mentorship to junior staff
Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects
Expertise in liquid chromatography, protein chemistry and mass spectrometry of protein molecules, including glycoproteins, experience in LC and LC-MS method development and qualification
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.