Process Development Scientist - Analytical Chemist

Career Category

Job 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 Scientist - Analytical Chemist

Live

What you will do

Let’s do this. Let’s 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.

• Develop strategies and implement methodologies for process development of late phase synthetic clinical programs.
• Develop, optimize, and authorize analytical methods for synthetic small molecules, synthetic peptide, and/or SiRNA release testing and characterization.
• Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
• Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.
• Lead activities at contract manufacturing and testing sites.
• May lead method transfer to CMO or contract testing labs.
• Review and approve protocols, reports from CMO and contract testing labs.
• Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
• May lead and mentor 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:

• Bachelor’s degree and 4 years of Scientific experience; OR
• Master’s degree and 2 years of Scientific experience; OR
• Doctorate degree

Preferred Qualifications:

• MS or PhD in Analytical Chemistry, Organic Chemistry, Biochemistry, Material Sciences or equivalent.
• Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
• Experience in analytical method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
• Experience in fundamental programming skills (such as Python, MATLAB, etc.) is preferred.
• 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.
• 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, able to manage deliverables against timelines.
• Excellent 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
• 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

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 perso