Amgen Process Development Senior Associate Scientist in West Greenwich, Rhode Island
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.
As a Process Development Senior Associate Scientist, this role will be a member of the Commercial Attribute Sciences group in Amgen Rhode Island.
Execute routine and characterization testing using multiple analytical methods and technologies to support commercial and NPI programs.
Interact and collaborate with other functional areas in matrix environment as analytical subject matter
Interpret results, author and review technical reports and sections of regulatory filings.
Support process and method lifecyle management, including testing to support process improvements, Comparability, small-scale models and method transfers, qualifications, and remediations.
Support site Forensics team in commercial manufacturing and PD investigations.
Basic Qualifications :
Master's degree and 3 years of Scientific experience
Bachelor's degree and 5 years of Scientific experience
Preferred Qualifications :
Scientist with 5+ years of experience in providing and driving analytical deliverables for biopharmaceutical processes and product development
Deep understanding of product quality attributes control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product
Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing
Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
Demonstrated experience working in matrix environment
Experience in data analysis, statistical analysis, setting acceptance criteria, comparability studies, and process/method transfers
Experience in applying troubleshooting and investigation methodologies for problem solving. This includes technical support for nonconformance investigations and other commercial support activities.
Strong technical writing, verbal communication and presentation skills
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
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.