Process Development Scientist - Pivotal Drug Substance Technologies
- Employer
- Amgen
- Location
- Cambridge, MA, US
- Start date
- Jul 18, 2019
View more
- Discipline
- Engineering, Manufacturing & Production, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
Pivotal Drug Substance Technologies team responsible for developing innovative solutions to prepare our small molecule and hybrid drug candidates.
Key Activities for the Process Development Scientist include:
- Develops technology to manufacture drug candidates in a practical, efficient, and safe manner
- Champions innovative applications of synthetic chemistry, pharmaceutical manufacturing, process analytical technologies (PAT), automation, and data analysis
- Provides significant 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 expert 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 current Good Manufacturing Practice (cGMP) operation and carry out deliveries of drug substance in a cGMP manufacturing environment
Basic Qualifications:
Doctorate degree
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 demonstrated 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, SciFinder, and electronic laboratory notebooks
Amgen focuses on areas of high unmet medical need and leverages 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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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