Amgen

Process Development Scientist-Continuous Processes

Employer
Amgen
Location
Cambridge, MA, US
Posted
May 30, 2019
Ref
R-75703
Required Education
Doctorate/PHD/MD
Position Type
Full time
Amgen is seeking a Process Development Scientist- Control of Continuous Processes to join our team and work from Amgen's beautiful Cambridge, Mass campus. To learn more about this position:

Duties Include:

Amgen's Process Development organization is seeking a highly qualified candidate to join the Attribute Sciences team responsible for developing creative solutions to control our small molecule drug candidates manufactured via continuous processing.

The scientist will provide process analytical technology and continuous manufacturing expertise, devising control strategies and new technologies to enable continuous synthetic processing.

Defines analytical control strategies for continuous manufacturing processes supporting clinical and commercial synthetic (small molecule) programs

Champions innovative applications of integrated continuous manufacturing, coupling process analytical technology (PAT) with synthetic flow chemistry, automation and data analysis.

Serves as a technical expert and keeps current in process analytical technologies supporting continuous manufacturing in pharmaceutical development including literature and technology development

Collaborates closely with drug substance and drug product process development colleagues

Leads activities at contract manufacturing and testing sites

Uses analytical science to help drive efficient development and scalable understanding of continuous processes and products in Amgen's pipeline

May lead and develop a small group of scientists

Basic Qualifications:

Doctorate degree or Doctorate degree completed by December 2018

OR

Master's degree and 4 years of Scientific experience

OR

Bachelor's degree and 6 years of Scientific experience

Preferred Qualifications:

PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering

2+ year's post-PhD experience in the pharmaceutical or biotech industry supporting analytical method development and process analytical technology for continuous processing

Deep understanding of small molecule analysis, chromatographic and spectroscopic techniques with an emphasis toward Process Analytical Technologies (PAT) for process understanding and process control.

Experience in a wide variety of analytical and physiochemical techniques including chromatography (High- Performance Liquid Chromatography: HPLC, Gas Chromatography: GC, Capillary Electrophoresis: CE) mass spectrometry, Ultraviolet: UV, Nuclear Magnetic Resonance: NMR, Fourier Transform Infrared: FTIR, Raman, particle size determination, crystal characterization, dissolution, etc., is preferred.

Developing and implementing methods for in-process testing, release and stability testing

Experience in analytical testing requirements for immediate release and controlled release solid dosage forms, liquid formulation or lyophilized formulation

Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development, etc.

Deep understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner

Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, lead deliverables against timelines

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

Works well in cross-functional teams, and across various geographic locations in different time zones

Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

Amgen provides a collaborative and creative culture in a company with a proven track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs 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.