Process Development Scientist

Amgen's Process Development organization is seeking a Scientist to join the Pivotal and Commercial Synthetics team and be responsible for developing innovative solutions to prepare our small molecule and hybrid drug candidates. The scientist will be principally concerned with translating developmental processes into commercial manufacturing reality using synthetic organic chemistry through scientific expertise, engineering innovation and deployment of manufacturing technologies.

This lab-based position will be responsible for support of the development, characterization, scale-up and support of chemical processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. With Amgen's biology first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from traditional synthetics to siRNAs and peptides.

Responsibilities:

• Develops technology to manufacture drug candidates in a practical, efficient, and safe manner.
• Fosters innovative applications of synthetic chemistry, pharmaceutical manufacturing, process analytical technologies (PAT), automation and data analysis.
• Provides meaningful contributions to drug substance development teams (e.g., product and process development teams, product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.
• Serves as a technical specialist and keeps current in organic chemistry and applications of process technology in pharmaceutical development including literature and technology development.
• Improves the technical or scientific capabilities of the department and routinely answers questions on or resolves scientific/technical issues.
• Collaborates in cross-functional teams to develop Amgen's pipeline.
• Works cross-functionally to deliver regulatory documents and supporting documentation in support of Amgen's regulatory filings.
• Delivers processes amenable to manufacturing operations and carry out deliveries of drug substance in a cGMP manufacturing environment.
• Optimally participates on drug substance development teams as a team member.
• Works optimally in a multi-disciplinary team of chemists, engineers and attribute scientists.
• Collaborates with other scientists and professionals outside the department.

Basic Qualifications:

Doctorate degree or Doctorate degree by May 2021

OR

Master's degree and 4 years of scientific experience

OR

Bachelor's degree and 6 years of scientific experience

Preferred Qualifications:

• Doctorate degree in Organic Chemistry, Medicinal Chemistry or Synthetic Chemistry
• Post-doctoral research experience
• Track record of proven scientific accomplishments in the field of organic chemistry
• Ability to champion new technologies
• Experience in the pharmaceutical / biotech or related industry that includes participation and contribution to scientific project teams
• Familiarity with common industrial unit operations including crystallization (batch and continuous mode), filtration and drying
• Familiarity with the use of design of experiments (DoE) and Process Analytical Technology (PAT) techniques
• Familiarity with laboratory automation, data analysis and visualization techniques and tools
• Familiarity with Environmental Health and Safety expectations for chemical laboratories
• Familiarity with current Good Manufacturing Practices for preparing drug substances and intermediates
• Demonstrated ability to effectively work in a fast-paced team environment
• Excellent interpersonal, presentation, written and verbal skills
• Knowledge of basic office and chemistry software including Microsoft Word, Excel, PowerPoint, ChemDraw, and SciFinder

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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 demonstrates 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.