Senior Specialist, Quality Control (Microbiology)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

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.

Senior Specialist, Quality Control (Microbiology)

What you will do

Lets do this. Lets change the world. In this vital role you will act as a Technical SME and Contamination Control Lead for the Quality Control Microbiology department, supporting implementation of new technologies at the local and global level, leading interdepartmental investigations, and supervising technical activities such as method validation and investigatory testing. The Senior 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.
• 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.
• Lead or support contamination control assessments and investigations, working closely with manufacturing operations and the global network.
• 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.
• Supervise planning and execution of new instrument installation and validation.
• 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, lead, and participate in laboratory investigations, deviations, and CAPAs.
• Act as coach and mentor for junior staff and perform training for microbiological techniques and assays.

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 12 years of related GxP laboratory experience OR
• Associates degree and 10 years of related GxP laboratory experience OR
• Bachelors degree and 6 years of related GxP laboratory experience OR
• Masters degree and 4 years of related GxP laboratory experience OR
• Doctorate degree and 2 years of related GxP laboratory experience

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: Endotoxin, Bioburden, PCR, Microbial Identification, TOC.
• Strong understanding of contamination control as it relates to pharmaceutical manufacturing processes.
• Experience leading projects with scope that encompasses multiple teams/partners.
• Strong fundamental understanding of design of experiment.
• Experience with method qualification and validation.
• Experience with instrument validation.
• Proven understanding of aseptic technique.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Maintains a detailed understanding of GxP Regulations and industry standards.
• Able to flexibly work independently, as a project owner/manager, collaboratively on group tasks, and as a trainer.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.