Senior Manager Quality Control Bioassay

Amgen - Holly Springs, NC

Full-time - Mid Level

Holly Springs, NC

5,001-10,000 employees

Chemical Manufacturing

About the position

The Senior Manager Quality Control Bioassay at Amgen will lead a team responsible for the QC Bioassay laboratory, focusing on the startup and validation of laboratory equipment and the transfer of analytical methods. This role is crucial for supporting Amgen North Carolina's commercial product release and involves ensuring compliance with safety guidelines and regulatory requirements. The position emphasizes fostering a culture of Safety, Quality, and Lean Leadership while driving operational excellence and efficiency within the global QC network.

Responsibilities

• Lead the QC Bioassay laboratory team and oversee day-to-day operations.
• Manage the startup and validation of laboratory equipment and analytical methods.
• Ensure compliance with safety guidelines, cGLPs, cGMPs, and regulatory requirements.
• Create and approve SOPs, trend data, investigations, deviations, and validation protocols.
• Participate in regulatory agency inspections and support site licensure.
• Establish and enable LEAN principles across all areas of responsibility.
• Interface with management on significant matters and coordinate activities across organizational units.
• Translate complex data into actionable information to meet business objectives.
• Identify process gaps and lead operational excellence projects to improve efficiency.

Requirements

• High school diploma/GED with 12 years of analytical testing experience, or an Associate's degree with 10 years, or a Bachelor's degree with 8 years, or a Master's degree with 6 years, or a Doctorate with 2 years of analytical testing experience.
• Minimum of 2 years of experience directly managing people or leading teams, projects, or programs.

Nice-to-haves

• Degree in a scientific field such as Molecular Biology, Biochemistry, or Pharmaceutical Sciences.
• Previous experience in qualification and validation of equipment and test methods.
• Strong knowledge of aseptic techniques and cGMPs.
• Experience interacting with regulators.
• Ability to drive process improvement within the area of responsibility.
• Strong leadership, collaboration, and communication skills.

Benefits

• Competitive salary
• Comprehensive Total Rewards Plans
• Support for professional and personal growth and well-being