Process Development Sr Principal 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

• Lead a team of analytical scientists responsible for developing, transferring, validating, and implementing analytical methods to support late-phase oligonucleotide programs through commercialization.
• Provide scientific, technical, and strategic leadership, driving the development and application of analytical tools to characterize critical quality attributes and advance product and process understanding.
• Shape analytical control strategies and enable successful process performance qualification (PPQ), regulatory submissions, marketing authorization, and commercial launch.
• 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, synthetic peptide, and/or SiRNA manufacturing, release 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.

Requirements

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

Qualifications

• Doctorate degree PhD OR PharmD OR MD and 3 years of Scientific experience OR Master’s degree and 6 years of Scientific experience OR Bachelor’s degree and 8 years of Scientific experience
• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for small molecule, peptide, and/or oligonucleotide drug substances and products.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
• Strong understanding of peptide and/or oligonucleotide structural elucidation and characteristics that relate to quality of peptide and/or oligonucleotide.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing.
• Strong experience in oligonucleotide method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
• 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 concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile.
• Able 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.

Preferred Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for small molecule, peptide, and/or oligonucleotide drug substances and products.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
• Strong understanding of peptide and/or oligonucleotide structural elucidation and characteristics that relate to quality of peptide and/or oligonucleotide.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing.
• Strong experience in oligonucleotide method development, characterization, and analytical control strategy especially having mass spectroscopy (MS) experience.
• 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 concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile.
• Able 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.