Senior Microbiologist Associate

1 day ago

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

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

Job Summary

We are seeking a highly motivated and experienced Supervisor/Senior Quality Control Associate, Microbiology to join our growing team at AmplifyBio. The successful candidate will be responsible for performing routine environment and utilities monitoring sampling and testing, as well as contributing to the QC laboratory maintenance and lab operations systems.

Key Responsibilities
  • Perform routine environment and utilities monitoring sampling and testing, including microbiological test procedures (e.g. sterility and bioburden) 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.
  • Conduct work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), Code of Federal Regulations (CFR), and other applicable regulatory guidance's.
  • Communicate clearly and concisely, both verbally and in the form of written reports, including contributing to drafting protocols and revising laboratory procedures necessary for the operation of the QC Microbiology and QC department.
Requirements
  • Bachelor's degree in relevant biological sciences (Microbiology degree preferred) with 5+ years of experience.
  • Experience in pharmaceutical or biotechnology industry laboratory or in an academic laboratory, with hands-on experience with microbiology, environmental/utilities/personnel monitoring methods, such as air sampling, growth promotion, microbial identification and/or sterility testing.
  • Ability to excel in a fast-paced team environment, handle multiple tasks concurrently, and deliver in a timely fashion.
  • Highly self-motivated and goal-oriented, with a bias for action, excellence, and the health and safety of employees.
What We Offer
  • Competitive compensation package.
  • Health, dental, and vision insurance that starts on your first day at AmplifyBio.
  • Flexible PTO policy.
  • Generous paid parental leave.
  • Wellness and self-care programs.
  • 401(k) match.
  • Tuition reimbursement.
  • EAP/work-life support system.
About Us

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. We hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

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