Principal Scientist Full-time

Amgen Operations Job Description

Join Amgen's mission of serving patients. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Scientist

What you will do

Let's do this. Let's change the world. In this vital role, you will apply your knowledge and skills to perform analytical development of late-stage biological therapeutics. In your daily work you will:

• Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.
• Provide analytical testing support to functions including but not limited to Drug Substance Technologies, Quality, and Manufacturing
• Leverage latest advances in protein analytics to develop, optimize, troubleshoot, remediate, qualify, validate and transfer analytical methods
• Design and execute analytical studies to support process and product characterization for late stage development products utilizing protein chemistry, separation sciences and mass spectrometry
• Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents
• Lead project teams and/or project sub-teams to meet program goals
• Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a leader with these qualifications:

Basic Qualifications:

• Bachelor's degree and 7 years of Scientific experience; Or
• Master's degree and 5 years of Scientific experience; Or
• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience

Preferred Qualifications:

• Advanced degree in Analytical Chemistry or related area with extensive experience performing independent scientific research
• Four or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
• Strong and in-depth expertise in multiple analytical techniques (i.e., SE-HPLC, RP-HPLC, CE, LC-MS); characterization of protein modifications with glycan mapping and peptide mapping.
• Experience in method transfers, method validation, method troubleshooting, and complex investigations.
• Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
• Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience preparing for and responding to RTQ, including assessment of CQAs, product quality targets and attribute risk assessment.
• Strong oral and verbal communication skills, ability to interact effectively with diverse internal and external stakeholders.
• Proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, ability to multitask, effectively plan and follow through on complex projects.
• A self-starter with strong decision-making skills, who thrives in collaborative matrix environment and can provide cross-functional leadership and mentorship to junior staff.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.