Sr. Scientist
1 week ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr. Scientist - Analytical Chemist
Live
What you will do
Lets do this Lets 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.
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 a team player with these qualifications.
Basic Qualifications:
Bachelors degree and 5 years of Scientific experience OR
Masters degree and 3 years of Scientific experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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.
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