Process Development Principal Scientist Analytical Chemist

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Scientist

What you will do

Lets do this! Lets change the world! In this vital role you will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and/or siRNA programs. The Scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.

Our Pivotal Attribute Sciences Department plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.

• Lead and mentor a group of analysts in supporting Process Development. Provide career development guidance to the team members.
• Lead analytical method development for synthetic small molecules and/or synthetic peptide testing and characterization.
• Collaborate closely with drug substance and drug product Process Development colleagues to achieve project objectives.
• Define analytical control strategies and implement methodologies for development of late phase clinical programs.
• Provide concise summary to cross-functional leadership for endorsement of key decisions.
• Oversee activities at contract manufacturing and testing sites.
• Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities.

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 Scientist with these qualifications.

• Bachelors degree and 7 years of scientific experience OR
• Masters degree and 5 years of scientific experience OR
• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of scientific experience

• PhD in Analytical Chemistry, Biochemistry with emphasis in mass spectrometry
• 3+ years experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for peptide drug substances and products.
• 2+ years experience as a people manager
• Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
• Experience in peptide method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
• Experience in method development and characterization related to innovative peptide synthesis is a plus.
• Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
• Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents

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

Objects in your future are closer than they appear. Join us.

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.