Amgen

Process Development Sr. Scientist

Employer
Amgen
Location
Cambridge, MA, US
Posted
May 22, 2019
Ref
R-74525
Required Education
Doctorate/PHD/MD
Position Type
Full time
Process Development Sr. Scientist - This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analyzes for manufacturing process development.

Responsibilities include:

Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: impurity 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, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions

May participate or 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 for cutting edge and regulatory driven activities

Supporting analytical projects involving method development, qualification, and transfer

Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions

Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.

Basic Qualifications:

Doctorate degree & 2 years of Scientific experience

OR

Master's degree & 6 years of Scientific experience

OR

Bachelor's degree & 8 years of Scientific experience

Preferred Qualifications:

Experience and expertise with molecular biology, particularly qPCR and DNA isolation.

Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.

Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.

Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines

Innovation - positive approach to challenges; supports new ideas and initiatives; brings out and utilizes others' creativity to improve group performance

Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered

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

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.