Amgen Process Development Associate Scientist Biological Relevance and Characterization in Cambridge, Massachusetts

Amgen is a biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering innovative human therapeutics. Amgen's Attribute Sciences group within Process Development (PD) is seeking a Process Development Associate Scientist. The PD Associate Scientist is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.

Responsibilities include:

Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations

Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions

Generating and analyzing analytical data to support: product development investigations and regulatory submissions

May contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation

Keeps current in analytical development field including literature and technology development

Supporting analytical projects involving method development, qualification, and transfer

Basic Qualifications

Master's degree and 2 years of Scientific experience

OR

Bachelor's degree and 4 years of Scientific experience

Preferred Qualifications

Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins

Expertise in cell-based bioassay development (method characterization, qualification, validation, technical transfer)

Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies

Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines

Innovation - supports new ideas and initiatives

Detail oriented and excellent documentation skills

Experience with automated liquid handling

Client orientation- establishes effective and responsive relationships with all clients; ensures value is delivered

Communication and Interpersonal skills - communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well 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.