Analytical Chemist - Process Development Senior Scientist

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.

Analytical Chemist - Process Development Senior Scientist

What you will do

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

Amgen is currently seeking a Sr. Scientist - Analytical Chemist in our Pre-Pivotal Development team in Rockville, MD.

This group is responsible for early phase analytical development, including method development, method qualification, method transfer, process and product development support. The individual will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for early phase protein therapeutic programs. The Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings.

• Work in a cross-functional team environment to advance therapies in early-stage development.

• Analyze early-stage protein-based therapies with advanced techniques such as liquid chromatography, mass spectrometry, capillary electrophoresis, as well as other methods.

• Troubleshoot and maintain laboratory equipment.

• Analytical method development, qualification, transfer to GMP group.

• Support process development including upstream (cell line, cell bank, cell culture development), downstream (impurities analysis, in process testing), formulation group (formulation screening, compatibility) and protein characterizations. Support research group’s molecules generations, validation, and potential new molecule nomination for clinical study.

• Define analytical control strategies and implement methodologies for development of early phase clinical programs.

• Mange project work packages or workflows independently.

• Integrates results both within work group and cross-functional groups into experimental design.

• Other duties include data analysis, preparation of electronic notebook records of experimental data, authorship of technical protocols and reports, presentation of results at team meeting, and support for regulatory filings as needed.

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:

• Excellent laboratory skills with 3+ years of experience in industry laboratories supporting analysis and characterization of protein therapies.

• Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including LC-MS, HIC, SEC, IEX, RP, HILIC, CE-SDS, cIEF etc.

• Expertise handling, troubleshooting, and maintaining CE and LC/MS instruments

• Expertise using CE and LC/MS operation and data analysis software.

• Ability to develop and implement methods for in-process, release, and stability testing.

• Strong understanding of protein analysis, structure elucidation and characterization.

• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner.

• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile.

• Works well i