Process Development Sr Scientist

About the role

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 our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Define analytical control strategies and implement methodologies to support the development of late-phase clinical programs, with a strong ability to articulate the challenges and complexities associated with analytical control strategy development.
• Develop, optimize, authorize and validate analytical methods for attribute understanding and characterization across synthetic modalities, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody–drug conjugates.
• 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.
• May lead activities and method transfer to contract manufacturing organization (CMO) or contract testing lab (CTL). Review and approve protocols, reports from CMO and CTL.
• 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.

Qualifications

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of Scientist experience OR Bachelor’s degree and 5 years of Scientist experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
• Experience in conjugates method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
• Strong understanding of synthetic molecule analysis and structure elucidation informed by knowledge of organic chemistry.
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