Process Development Senior Scientist

Join Amgen’s mission of serving patients. At Amgen, 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. 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.

About the role

In this vital role, you will join the integrated Pharmaceutical Attribute Sciences (iPAS) department, located in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products. The analytical scientist 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 analytical 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.

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, 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.
• May lead activities and method transfer to contract manufacturing organization (CMO) or contract testing lab (CTL). Review and approve protocols and 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.

Requirements

• Doctorate degree OR Masters degree and 2 years of Scientific experience OR Bachelors degree and 4 years of Scientific experience OR Associates degree and 8 years of Scientific experience OR High school diploma / GED and 10 years of Scientific experience

Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• 2+ years post-PhD 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 peptide method development, characterization, and analytical control strategy, especially with mass spectroscopy (MS).
• 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.

Pay

This role is paid hourly. The expected annualized salary range for this role in the U.S. (excluding Puerto Rico) is $xxx,xxx.00 to $xxx,xxx.00. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

Benefits

• 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 where possible.