Senior Manager Quality Control - Chemistry

20h20 hours ago

Amgen

Holly Springs, US · Full-time · $142,104 – $192,258

About this role

At Amgen, you will be part of a mission to serve patients living with serious illnesses through innovative biotech medicines. As Senior Manager Quality Control - Chemistry, you will lead the QC Chemistry laboratory and operations for 1st and 2nd shifts during site startup and into commercial manufacturing.

In this role you will oversee startup and validation of laboratory equipment along with transfer and implementation of analytical methods. Scope covers in-process release stability and characterization testing to support commercial manufacturing at Amgen North Carolina.

You will report to the Director of Quality Control and serve on the QC leadership team. The position requires fostering a culture of safety quality collaboration accountability and Lean Leadership across all laboratory functions.

Success depends on building a high-performing organization that delivers both startup execution and long-term 24/7 commercial operations. You will partner cross-functionally and participate in regulatory inspections to support site licensure and ongoing manufacturing readiness.

Requirements

Experience leading QC Chemistry laboratory operations in pharmaceutical manufacturing under cGMP requirements.
Strong knowledge of analytical method families including HPLC/UPLC capillary electrophoresis and compendial chemistry testing.
Proven ability to manage multi-shift laboratory teams and transition organizations from startup to routine commercial operations.
Experience implementing digital tools and Lean principles to improve laboratory performance and compliance.
Demonstrated success partnering with Manufacturing Process Development and Quality Assurance on cross-functional projects.
Track record supporting regulatory agency inspections and maintaining inspection readiness in GMP environments.

Responsibilities

Lead startup operational readiness and day-to-day management of the QC Chemistry laboratory and 1st and 2nd shift QC teams.
Lead QC Chemistry functions supporting chromatography capillary electrophoresis gel-based methods and compendial chemistry testing.
Manage 1st and 2nd shift managers 7 days a week for cross-functional night shift support for manufacturing.
Ensure laboratory and shift operations comply with safety guidelines cGLPs cGMPs and applicable regulatory requirements.
Build lead coach and develop a high-performing organization supporting both startup and long-term commercial operations.
Partner cross-functionally with Manufacturing Process Development Quality Assurance and other site functions to support startup readiness.
Participate in regulatory agency inspections and support site licensure and inspection readiness activities.
Establish and drive Lean principles to improve operational performance reliability efficiency and compliance.