Process Development Senior Scientist

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Let’s do this. Let’s change the world. In this vital role you will be responsible for analytical and biochemical characterization activities for pre-clinical biotherapeutic protein development including assay development for biochemical characterization with emphasis on mass spectrometry and liquid chromatography, planning and execution in support of pre-clinical candidate selection, process development and lead molecule characterization. The ideal candidate will support product advancement by developing analytical methods that assess biochemical characteristics of the candidate drug product with peptide mapping and intact protein LC-MS analysis.

Sample preparation including reduction/alkylation, enzymatic digestion of therapeutic proteins, liquid chromatography, mass spectrometry, and peptide mapping workflows is needed.

• Specific activities include characterizing candidate molecules to support protein primary structure as well as characterizing drug candidate chemical and post-translational modifications (quality attributes).
• Automation platforms and liquid handling systems are used. Generation of technical documents and technical presentations is required.
• This position is also responsible for providing scientific results that support the generation of regulatory submissions, patents, and publications and exploring and evaluating emerging technologies relevant to MS-based characterization of therapeutic proteins.

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:

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
OR
Master’s degree and 3 years of scientific experience
OR
Bachelor’s degree and 5 years of scientific experience

Preferred Qualifications:

• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, physical sciences, chemical engineering, or biological sciences.
• Expertise with mass spectrometry of proteins, peptides and glycans.
• Expertise with Thermo mass spectrometers, Agilent and Thermo HPLC. systems, and corresponding data acquisition software such as Chromeleon.
• Expertise with mass spectrometry data processing software packages (Bio Pharma Finder, Skyline, Byonic, Byos, Expressionist).
• Expertise with statistical software, including Excel or Origin, is recommended.
• Experience with in the biotech industry, experience to include data analyses, statistical analysis, setting acceptance criteria in support of process development, process/method transfers, and comparability studies.
• Good problem-solving skills requiring the application of scientific theory
• Strong laboratory work skills to include the design and performance of scientific experiments and interpretation of results.
• Excellent written and oral communication skills for the timely documentation,…