Description
**HOW MIGHT YOU DEFY IMAGINATION?**
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Process Development Sr. Scientist – Analytical Chemist**
**Live**
**What you will do.**
**Let’s do this! Let’s change the world!**
Amgen is currently seeking a Sr. Scientist – Analytical Chemist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for early phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The individual 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 early phase synthetic programs. The Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings. The Sr. Scientist should have strong analytical chemistry and communication skills.
**Key Responsibilities:**
+ Analytical method development, validation and trouble-shooting for small molecule drug substances and drug products and in-process testing
+ Define analytical control strategies and implement methodologies for development of early phase clinical programs.
+ Collaborate 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.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
**Basic Qualifications:**
+ Doctorate degree completed by time of hire 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
+ 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 physio-chemical 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, handle 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 synthesis, method development and attribute characterization for small molecules, peptides or oligonucleotides
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
+ Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans and bi-annual company-wide shutdowns
+ Flexible work models, including remote work arrangements, where possible
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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 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 accommodation.
