Amgen · 15 hours ago
Manager, Quality Control Microbiology
Holly Springs, NC
Full-time
Onsite
Senior Level
5+ years expAmgen is a pioneering biotech company dedicated to serving patients with serious illnesses. The Manager, Quality Control Microbiology will oversee the Sampling and Testing teams within the Quality Control Microbiology laboratory, ensuring compliance with environmental monitoring and microbiological testing to support drug substance manufacturing.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Preferred
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
Benefits
Competitive benefits
Comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-24
2026-01-22
Company data provided by crunchbase