Process Development Scientist - Analytical
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Process Development Scientist - Analytical
What you will do
Lets do this. Lets change the world. In this vital role you will be joining 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.Key Responsibilities:
- 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.
- Drug product development, analytical development, method development, dissolution
- Manage activities at contract manufacturing and testing sites.
- May lead and develop a small group of scientists.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The analytical professional we seek is an emerging Scientist with these qualifications.Basic Qualifications:
Doctorate Degree by June 2021 OR
Master's Degree + 4 years of scientific experience OR
Bachelor's Degree + 6 years of scientific experiencePreferred Qualifications:
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
- 2+ years post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.
- Experience in a wide variety of structure elucidation and physicochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
- Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
- 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 small molecules
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.