Process Development Principal Scientist

Amgen • Thousand Oaks, CA

113d • $148,363 - $171,657 • Hybrid

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. 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.

Requirements

• 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.
• Proven track record problem solving and troubleshooting in a process development environment.
• Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems.
• Advanced understanding of cell culture and/or purification techniques, bioreactor production, harvest operations, protein chromatography, TFF, filtration, etc.
• Experience with drug substance commercialization activities, including interactions with regulatory agencies.
• Familiarity with design of experiments and statistical analysis of data.
• Track record of innovation and demonstrated eminence in the scientific community through a sustained record of peer-reviewed publications.
• Motivated self-starter with excellent interpersonal and organizational skills.
• Excellent verbal communication and scientific writing skills.
• Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists.

Nice To Haves

• Doctorate in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with 4+ years of experience.
• Demonstrated success working with diverse team members in a dynamic, cross-functional environment.

Responsibilities

• Manage an integrated group of cell culture and purification scientists.
• Advance Amgen's pipeline by developing, characterizing, and supporting clinical drug substance manufacturing processes.
• Lead the development, characterization, scale-up, and support of upstream and downstream drug substance processes.
• Apply platform approaches and utilize problem-solving skills to solve development challenges.
• Build robust processes with efficient experimentation.
• Develop strong teams and support staff in their career development.
• Work closely with Research, Attribute Sciences, Drug Product Technologies, Clinical Manufacturing, and partners in the Amgen network.
• Lead matrix cross-functional teams to deliver robust drug substance data packages for clinical advancement.
• Author CMC sections of regulatory documents and interact with regulatory agencies.
• Support technology transfers and work with various contract development and manufacturing organizations.
• Drive innovation and support technology advancement efforts.
• Expand Amgen's external eminence and represent Amgen in the external scientific community.

Benefits

• Comprehensive employee benefits package including 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.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree