Process Development Senior Associate - Drug Substance Technologies - Synthetics (DSTS)

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 Associate - Drug Substance Technologies - Synthetics (DSTS)

What you will do

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

Amgen is currently seeking a talented Process Development Senior Associate to join our Drug Substance Technologies - Synthetics (DSTS) group. Amgen’s DSTS group within Process Development (PD) is responsible for the invention, development, and implementation of drug substance manufacturing processes and technologies to advance Amgen's exciting portfolio of synthetic and hybrid assets. Senior Associates in our team collaborate with chemists, process engineers, and attribute scientists to support drug substance manufacturing from early to late-stage development. The successful candidate will be a highly motivated and team-oriented individual with prior lab-based research experience in organic chemistry or biochemistry/chemical biology.

Key Responsibilities:

• Work within a drug substance team comprised of chemists, engineers, and attribute scientists to solve technical problems

• Contribute to the invention of synthetic routes and development of safe, robust, and cost-effective processes to manufacture synthetic and hybrid drug substances

• Support cGMP manufacturing and technology transfer to our internal manufacturing facilities and external contract manufacturers

• Support process characterization activities, including process understanding and modeling

• Contribute to drug substance development teams by providing experimental results, technical updates, documentation, data interpretation, recommendations, etc.

• Works regularly with a supervisor to advance projects within required deadlines.

• Work cross-functionally to deliver regulatory documents and support regulatory filings

• Follows good laboratory documentation practices and standard operating procedures

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 a collaborator with these qualifications.

Basic Qualifications:

• High school diploma / GED and 6 years of Scientific experience OR

• Associate’s degree and 4 years of Scientific experience OR

• Bachelor’s degree and 2 years of Scientific experience OR

• Master’s degree

Preferred Qualifications:

• M.S. in organic chemistry or biochemistry/chemical biology with a specialization in synthetic/conjugation chemistry, synthetic methodology, total synthesis, peptide/protein chemistry, or oligonucleotide chemistry

• Prior experience with ADC development, bioconjugation, or related modalities

• Proficiency in analytical characterization techniques such as Hydrophobic Interaction Chromatography (HIC)-HPLC, Size Exclusion Chromatography (SEC), Liquid Chromatography–Mass Spectrometry (LC-MS), Ion-Exchange (IEX), and Reversed Phase (RP)-HPLC.

• Experience working in pharmaceutical industry with expertise in synthetic peptide, oligonucleotide, and/or antibody drug conjugate process development

• Demonstrated ability to work in a chemistry laboratory with minimal supervision

• Ability to independently collect and interpret analytical results (NMR, HPLC, MS, IR, Raman, etc)

• Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on projects

• Experience working in cross-functional or matrixed teams

• A research summary included with CV is strongly encouraged

What you can expec