Manager, Quality Control Microbiology

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in single use 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 Amgens plan to be a carbon-neutral company by 2027.

Manager Quality Control Microbiology

What you will do

Lets do this. Lets change the this vital role you will manage the Sampling and Testing teams within the Quality Control Microbiology laboratory. This role oversees routine environmental monitoring clean utilities monitoring and routine microbiological testing to support drug substance manufacturing. The Manager Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology.

• Directly supervise Microbiology staff supporting routine Environmental monitoring and utilities monitoring sampling and testing and production in-process and final drug substance testing.
• Manage the training program for sampling and testing team.
• Assist with planning scheduling and lead execution of EMPQ and Clean Utilities qualification activities to support facilities changes.
• Assist the Environmental Monitoring and Utilities Monitoring program owner with sampling scheduling coordinating activities with manufacturing operations reviewing and interpreting data and writing trend reports.
• Act as Subject Matter Expert for method families and testing platforms used in the microbiology department.
• Work cross-functionally with Manufacturing Analytical Sciences Facilities & Engineering and Quality teams to align processes with business needs.
• Author revise and review documents and reports including but not limited to: SOPs safety assessments trend reports qualification/validation summary reports microorganism assessments and technical reports.
• Represent the microbiology department during agency inspections and internal audits.
• Work closely with the global Quality Control organization to drive standardization of testing processes and procedures.
• Own manage and participate in deviations CAPAs and cross functional investigations.
• Lead process improvement projects that may be local or global in scope.
• Support routine activities over the weekends and public holidays as required.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Manager 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 Quality or Aseptic Manufacturing experience OR
• Associates degree and 10 years of Quality or Aseptic Manufacturing experience OR
• Bachelors degree and 5 years of Quality or Aseptic Manufacturing experience OR
• Masters degree and 3 years of Quality or Aseptic Manufacturing experience OR
• Doctorate degree

And

In addition to meeting at least one of the above requirements you must have experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Strong leadership skills with the ability to manage multiple direct reports.
• Degree in Microbiology Biology Biochemistry or related scientific field.
• Experience with environmental monitoring and clean utilities monitoring including execution of EMPQ and trending of EM/utilities data.
• Experience with microbiological quality control testing including but not limited to: Endotoxin Bioburden Microbial Identification TOC.
• Experience with equipment validation.
• Solid understanding of aseptic technique.
• Strong written and verbal communication skills including technical writing and technical presentations.
• Able to flexibly work independently as a project owner 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 your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well 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.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse 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 and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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