Sr. Manager Quality Control - Chemistry

Responsibilities

• Lead the QC Chemistry laboratory and oversee 1st and 2nd shift operations to support commercial manufacturing.
• Manage the startup, validation, and transition of laboratory equipment and analytical methods into steady-state operations.
• Oversee analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), and gel-based methods.
• Build, coach, and develop a high-performing team capable of supporting 24/7 operational requirements.
• Ensure all laboratory activities comply with safety guidelines, cGLPs, cGMPs, and regulatory requirements.
• Partner cross-functionally with Manufacturing, Quality Assurance, and Supply Chain to ensure site readiness and process performance.
• Drive Lean principles and operational excellence initiatives to improve efficiency and compliance.
• Support regulatory agency inspections and site licensure activities.

Requirements

• Extensive experience in Aseptic Manufacturing (8 years with a Bachelor's, 6 years with a Master's, or 2 years with a Doctorate).
• Minimum of 2 years of direct people management or leadership experience.
• Strong expertise in analytical chemistry and chromatography techniques.
• Proven ability to manage complex technical data and lead cross-functional teams.

Preferred Qualifications

• Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field.
• Experience in a GMP pharmaceutical manufacturing environment with classified areas.
• Expertise in method transfer, qualification, and validation for commercial biologics.
• Experience with laboratory investigations, deviations, CAPAs, and change controls.
• Demonstrated success in driving Lean and continuous improvement initiatives within a QC organization.

Benefits

• Comprehensive health and welfare plans including medical, dental, and vision.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where applicable.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, delivering innovative medicines that help people live longer, fuller, and happier lives.