BioSpace
Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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 a 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
Interface and collaborate with other functional areas in a matrix environment, serving as an 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, 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 (e.g., 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 reviewing regulatory submission product quality sections and supporting documentation, including preparation for and response to RTQ, and assessment of CQAs, product quality targets, and attribute risk assessment.
Strong oral and verbal communication skills, and 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, and ability to multitask and effectively plan and follow through on complex projects.
A self‑starter with strong decision‑making skills who thrives in a 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 care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we support your journey every step of the way. A comprehensive employee benefits package includes: a retirement and savings plan with generous company contributions; group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; discretionary annual bonus program; stock‑based long‑term incentives; award‑winning time‑off plans; and flexible work models, including remote and hybrid arrangements, where possible.
Apply now and make a lasting impact with the Amgen team.
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Principal Scientist What You Will Do
Interface and collaborate with other functional areas in a matrix environment, serving as an 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, 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 (e.g., 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 reviewing regulatory submission product quality sections and supporting documentation, including preparation for and response to RTQ, and assessment of CQAs, product quality targets, and attribute risk assessment.
Strong oral and verbal communication skills, and 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, and ability to multitask and effectively plan and follow through on complex projects.
A self‑starter with strong decision‑making skills who thrives in a 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 care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we support your journey every step of the way. A comprehensive employee benefits package includes: a retirement and savings plan with generous company contributions; group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; discretionary annual bonus program; stock‑based long‑term incentives; award‑winning time‑off plans; and flexible work models, including remote and hybrid arrangements, where possible.
Apply now and make a lasting impact with the Amgen team.
#J-18808-Ljbffr