Senior Microbiologist

2 weeks ago


Albany, New York, United States AmplifyBio Full time
About AmplifyBio

AmplifyBio is a leading contract research organization that provides a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.

Job Summary

We are seeking a highly skilled Supervisor/Senior Quality Control Associate, Microbiology to join our growing team at AmplifyBio's Manufacturing Enablement Center in New Albany, OH.

Key Responsibilities
  • Perform routine environment and utilities monitoring sampling and testing, as well as microbiological test procedures for GMP in process and product lot release.
  • Contribute to the QC laboratory maintenance and lab operations systems, working with QC management to continuously improve QC operations procedures and systems.
  • Ensure compliance with FDA Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), Code of Federal Regulations (CFR), and other applicable regulatory guidelines.
  • Communicate effectively with colleagues and management, contributing to drafting protocols and revising laboratory procedures as necessary.
Requirements
  • Bachelor's degree in a relevant biological science, with 5+ years of experience in the pharmaceutical or biotechnology industry.
  • Proven experience in microbiology, environmental/utilities/personnel monitoring methods, and sterility testing.
  • Excellent communication and teamwork skills, with the ability to handle multiple tasks concurrently and deliver results in a timely fashion.
  • Self-motivated and goal-oriented, with a strong commitment to maintaining high-quality execution and documentation.
What We Offer
  • A competitive compensation package and comprehensive benefits, including health, dental, and vision insurance.
  • A flexible PTO policy and generous paid parental leave.
  • A fun and dynamic work environment, with opportunities for professional growth and development.
  • A commitment to diversity, equity, and inclusion, with a focus on creating a welcoming and inclusive workplace culture.

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