Amgen Analytical Chemist (Process Development Scientist) in Thousand Oaks, California
Amgen is currently seeking a Scientist - Analytical Chemist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for late phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products.
The Scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for late phase synthetic programs. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND/NDA filings.
•Define analytical control strategies and implement methodologies for development of late phase clinical programs.
•Collaborate closely with drug substance and drug product process development colleagues.
•Manage activities at contract manufacturing and testing sites.
•May lead and develop a small group of scientists.
Doctorate degree or Doctorate degree completed by May 2019
Master’s degree and 4 years of scientific experience
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 in process and product development and drug substance and drug product analytical method development.
•Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
•Experience in a wide variety of structure elucidation and physicochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
•Developing and implementing methods for in-process testing, release and stability testing.
•Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
•Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, early phase development, etc.
•Solid understanding of GLP and 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, manage deliverables against timelines
•Strong communication skills and ability to provide cross-functional leadership and guidance to 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
•Experience with solid state synthesis, method development and attribute characterization for peptides or oligonuecleotides
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.
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.
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 leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.