Analytical Sr Scientist

Amgen • Thousand Oaks, MA

1d

About The Position

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. Analytical Sr Scientist What you will do Let’s do this! Let’s change the world! In this vital role you will work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products. Responsibilities include: Integrate and successfully apply platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application. Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs. Collaborate closely with drug substance and drug product process development colleagues. Manage activities at contract manufacturing and testing sites. May lead and develop a small group of scientists.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of Scientific experience OR Bachelor’s degree and 5 years of Scientific experience
• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
• Experience in a wide variety of analytical techniques including chromatography(HPLC and UPLC) mass spectrometry, UV, NMR, FTIR, solid state characterization, etc.
• Developing and implementing methods for in-process testing, release and stability testing.
• Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
• 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
• Strong 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
• Works well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

Responsibilities

• Integrate and successfully apply platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application.
• Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
• Collaborate closely with drug substance and drug product process development colleagues.
• Manage activities at contract manufacturing and testing sites.
• May lead and develop a small group of scientists.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior