Career Category
Quality
Job Description
Senior Manager QC Microbiology
Live
What you will do
Let's do this. Let's change the world.
Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
The Senior Manager QC Microbiology is responsible for leading and managing the Micro and Environmental Monitoring teams. This role involves setting goals, managing performance, and providing clear direction in line with company goals, with safety as the foundation of all activities.
Key Responsibilities:
The Senior Manager is the key contact for microbiology-related activities for the site and network and leads the team during regulatory inspections, ensuring network alignment on commitments prior to agreement with agencies. They ensure that quality and compliance requirements are executed as established in the site's SOP and corporate guidelines, providing necessary coaching and guidance. The role requires managing multiple competing priorities, including site and functional responsibilities, frequent communications, and attending meetings as lead microbiologist on site. Most importantly they provide environmental compliance oversight to support aseptic production activities.
Win
What we expect of you
The successful candidate for this role will bring the following education, skills and experience
• Education: Bachelor of Science degree in Microbiology, Biology or related science discipline
• Experience: Minimum of 10 years of related experience in GMP Aseptic or Sterile Manufacturing environment, working in Environmental Monitoring and/or Microbiology laboratory. Strong Environmental Monitoring management experience in a sterile manufacturing site is required. Knowledge of current trends in Aseptic Manufacturing standards and regulatory compliance requirements for Pharmaceutical/Biological manufacturing is preferred.
• Leadership: Demonstrated leadership and management skills, including establishing direction and goals, guiding execution, and fostering a team-based environment. Demonstrated mentoring and coaching, influencing, negotiating, and personal interaction skills.
Thrive
What you can expect of us
In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.
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