Process Development Senior Scientist - Attribute Sciences

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Senior Scientist - Attribute Sciences

What you will do

Let’s do this! Let’s change the world!

This is an exciting opportunity to join the Amgen Biologics Pivotal Attribute Sciences team based in Cambridge, Massachusetts. In this role you will:

• Architect and deploy end-to-end assay automation including sample prep, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency.

• Develop, qualify/validate, and transfer protein analytical methods (e.g., CE-SDS, IEX, SEC, LC-MS), leveraging automation to improve throughput, reproducibility, and data integrity.

• Lead training, qualification, and transfer from our process development labs to our global quality network partners.

• Interpret analytical results, author and review technical protocols/reports, and contribute to analytical CMC sections in regulatory filing documents including IND and BLAs.

• Serve as analytical subject matter expert supporting characterization studies, data analysis, and investigations while interfacing and collaborating with our functional partners in a matrix environment.

• Design and execute late‑stage process/product characterization and forced‑degradation studies utilizing protein chemistry, separation sciences, mass spectrometry, and lab automation.

• Drive automation-enabled innovation in Process Development by standardizing methods and applying DoE to reduce assay cycle time and raise first-pass transfer rates.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 5 years of Scientific experience OR

• Master’s degree and 3 years of Scientific experience OR

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

Preferred Qualifications:

• Strong written and verbal communication skills, ability to interact effectively with diverse internal and external stakeholders

• 5+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics, including experience coordinating with QC laboratories to execute method transfers, validations and troubleshooting

• In-depth expertise in multiple analytical techniques (i.e., SE-HPLC, IEX, CE-SDS, LC-MS); characterization of protein modifications

• Expertise with laboratory automation including liquid handlers, pipetting robots, and automation software

• Experience in method transfers, method validation, method troubleshooting, and complex investigations

• Familiarity with and understanding of United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation

• Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions

• Proficiency in solving complex problems; ability to work independently, proactively seek outside resources and collaboration, effectively plan and follow through on complex projects

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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