QC Micro Manager

Career Category

Job Description

Join Amgen’s 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.  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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager QC Microbiology (L5)

Employment Type: Full-Time, Permanent

Work Pattern: Days

Role Overview

The Manager QC Microbiology is responsible for leading the QC Microbiology team and providing technical, quality and operational oversight of microbiology activities supporting Manufacturing. The role focuses on safety, compliance, operational delivery, continuous improvement, Lean principles and Right First Time (RFT) while ensuring an effective and efficient QC service.

Key Responsibilities

·       Lead, manage, coach and develop the QC Microbiology team.

·       Ensure QC Microbiology activities are performed safely and in compliance with cGMP, cGLP, SOPs and registered specifications.

·       Provide oversight of in-process, Environmental Monitoring, release and stability testing, including commercial and global release testing.

·       Provide oversight of relevant analytical in-process methods.

·       Ensure testing and associated GMP documentation are completed accurately and within required timelines.

·       Ensure timely completion of laboratory investigations, deviations and non-conformances, including effective root-cause analysis and CAPA.

·       Review and approve SOPs, investigations, trend reports, validation/verification documentation and equipment qualifications.

·       Monitor laboratory and Environmental Monitoring trends and identify opportunities for improvement.

·       Drive Lean, RFT and continuous improvement initiatives to improve laboratory performance and efficiency.

·       Maintain inspection readiness and participate in regulatory inspections and audits.

·       Manage team resources and priorities to support Manufacturing and business requirements.

·       Represent QC Microbiology on cross-functional projects and forums.

·       Identify and escalate quality, compliance, technical and operational risks appropriately.

Knowledge & Skills

·       Strong technical knowledge of pharmaceutical/biopharmaceutical microbiology and GMP laboratory operations.

·       Knowledge of Environmental Monitoring and aseptic manufacturing.

·       Strong investigation, problem-solving and decision-making skills.

·       Demonstrated people leadership, coaching and team development capability.

·       Strong GMP technical writing and documentation skills.

·       Effective planning, organisation and prioritisation skills.

·       Strong communication, presentation, influencing and stakeholder management skills.

·       Ability to independently manage multiple priorities and deliver against operational objectives.

·       Demonstrated ability to lead continuous improvement initiatives and drive sustainable change.

Education & Experience

Essential

·       Bachelor’s degree in a science-related discipline.

·       6+ years of biopharmaceutical QC, Quality Control or relevant GMP laboratory experience.

·       Experience working in a regulated cGMP manufacturing/testing environment.

·       Proven experience leading teams.

·       Strong experience with laboratory quality systems, investigations and GMP documentation.

Desirable

·       2–3 years of microbiology supervisory or management experience.

·       Experience with Environmental Monitoring and aseptic manufacturing.

·       Experience supporting regulatory inspections.

·       Experience leading cross-functional teams or projects.

·       Analytical experience relevant to oversight of in-process testing.

·       Experience implementing Lean, RFT or continuous improvement initiatives.


What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

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