Senior Associate Manufacturing - CAPA/EV

What We Do

Join Amgens 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Manufacturing (CAPA/EV)

Support deviations by owning the associated CAPA and EV records in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

• Manage deviation investigation CAPAs and EVs, including assembling teams, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Defend investigation CAPAs/EVs to regulatory inspectors and internal auditors.
• Present complex topics clearly to large and small groups at all levels in the company.
• Build effective relationships across functions.
• Clear and concise technical writing.

Basic Qualifications

• Masters degree OR
• Bachelors degree and 6 months of manufacturing experience OR
• Associates degree and 2 years of manufacturing experience OR
• High school diploma / GED and 4 years of manufacturing experience

Preferred Qualifications

• 4+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility.
• Degree in Science or Engineering.
• Experience leading teams.
• Demonstrated project management ability.
• Excellent written and verbal communication skills.
• Ability to work in a team matrix environment and build relationships with partners.

What You Can Expect From Us

• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

Pay & Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.