Specialist, Quality Control Microbiology

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist, Quality Control Microbiology

What you will do

Let’s do this. Let’s change the world. In this vital role, you will act as a Subject Matter Expert for PCR based assays, performing testing as required, and providing general oversight within the Quality Control Microbiology laboratory. The Specialist, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology.

• Act as Subject Matter Expert for method families and testing platforms used in the microbiology department, specifically PCR based assays.
• Act as coach and mentor for junior staff and perform training for microbiological techniques and assays.
• Assist with scheduling and coordinate STAT/rush requests from manufacturing.
• Perform PCR and other microbiological assay testing as needed.
• Collaborate with Global Process Owners to fulfill regulatory commitments.
• Represent the microbiology department in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Work closely with the global Quality Control organization to drive standardization of testing processes and procedures.
• Represent Amgen while participating in global forums relating to pharmaceutical microbiological testing advancements.
• Author, revise, and review documents and reports including but not limited to: SOPs, methods, trend reports, qualification/validation protocols, microorganism assessments, and technical reports.
• Lead method transfer activities for new products, working with the Global Method Implementation Team.
• Provide guidance on sampling strategies and in process testing strategies for new products.
• Provide oversight of method qualification and validation testing as needed.
• Lead process improvement projects that may be local or global in scope.
• Own, manage, and participate in laboratory investigations, deviations, and CAPAs.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality Control Microbiology Specialist we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality or Aseptic Manufacturing experience OR
• Associate’s degree and 8 years of Quality or Aseptic Manufacturing experience OR
• Bachelor’s degree and 4 years of Quality or Aseptic Manufacturing experience OR
• Master’s degree and 2 years of Quality or Aseptic Manufacturing experience OR
• Doctorate degree

Preferred Qualifications:

• Related experience in the pharmaceutical industry, preferable working in a GxP Microbiology lab.
• Degree in Microbiology, Biology, Biochemistry, or related scientific field.
• Experience with microbiological quality control testing, including but not limited to: PCR, Endotoxin, Bioburden, Microbial Identification.
• Experience managing projects with scope that encompasses multiple teams/stakeholders.
• Experience with method qualification and validation.
• Experience with instrument validation.
• Strong knowledge of aseptic technique.