Manager, Quality Control Microbiology

Amgen

About The Position

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 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 Amgen's plan to be a carbon-neutral company by 2027. Manager, Quality Control Microbiology What you will do Let’s do this. Let’s change the world. In 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.

Requirements

High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR Associate’s degree and 10 years of Quality or Aseptic Manufacturing experience OR Bachelor’s degree and 5 years of Quality or Aseptic Manufacturing experience OR Master’s degree and 3 years of Quality or Aseptic Manufacturing experience OR Doctorate degree
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

Nice To Haves

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.

Responsibilities

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.