Site Microbiologist


Baltimore (Bayview), MD, US, 21224


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.


This position is responsible for ensuring the Environmental Monitoring sampling/testing program and strategy aligns with the broader manufacturing control strategy for aseptic operations including gowning requirements, personnel/material flow, and cleaning/sanitization. 


This position serves as a technical contributor in microbiology quality with a technical competency.  This role supports compliance and risk-based evaluation and provides in-depth technical support for the manufacturing facility and operations supporting new and existing microbial controlled products, including technology concepts, process development and validation activities.  Responsible for actively networking with internal and external scientific, technical, and regulatory communities to maintain state-of-the-art knowledge.  Will provide microbiology support to facility, operations, and laboratory testing to trend and interpret Environmental Monitoring data to investigation excursions and drive continuous improvement.




Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Supports applied research and development initiatives, including integrating new technologies and test methods into routine practice.
  • Develops innovative microbiology ideas for sterilization/aseptic processing of products not amenable to traditional methods.
  • Assists in the development of the enterprise standards and guidance regarding microbiological methods for monitoring and controlling manufacturing processes.
  • Conducts technical assessments to qualify suppliers and other contract services (contract testing labs, third party manufacturers).
  • Leads the microbiology analyst training and implement training programs and initiatives to develop microbiological skills.
  • Assists in the development of strategies for microbiology laboratories.
  • Supports equipment qualifications to ensure accuracy and consistency of results.
  • Provides support and direction on new microbiology methods, process optimization, and troubleshooting out of specification (OOS) test results.  Determines root cause and prescribes robust effective corrective action.
  • Initiates and investigates non-conforming laboratory test results and escalates microbiological quality issues to management.
  • Leads and/or participates in the development of internal technical documents.
  • Assists in troubleshooting microbially nonconforming manufacturing processes.
  • Provides support to ensure that microbiological quality tactical objectives are aligned with strategic organizational targets.
  • Interfaces with internal regulatory compliance and external Regulatory Authorities during on-site inspections and related to submissions.


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.



  • Bachelor’s degree (or equivalent) in a relevant scientific/technical field AND 10 or more years of relevant experience (for example, lab testing, executing lab studies, developing and validating test methods to support Microbiological Quality / Sterility Assurance).
  • Experience managing complex laboratory studies, projects and processes while staying within budget. Solid understanding of key processes and activities within Microbiological Quality, and the interdependencies and interactions with other functions.
  • Understanding of practices, and/or scientific theories and principles regarding tests, studies, developments, and validation of test methods executed within Microbiological Quality.
  • Experience in aseptic operations including Environmental Monitoring Performance Qualification.
  • Experience in designing and/or sustaining control strategies intended to prevent microbiological contamination in manufacturing areas.
  • Experience leading, and/or providing instruction to, professional and technical employees on projects and initiatives.
  • Experience leading the troubleshooting of process non-conformances, out of specification test results, and failure investigations, as well as providing resolution to issues via robust CAPA.
  • Experience conducting audits of in-house Microbiology Labs, contract/external labs, manufacturing processes, and critical utilities (i.e. water systems, compressed gases, controlled environments).
  • Strong understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards, and maintains currency on pharmacopeia compendia.



There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.


Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.


  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Nearest Major Market: Baltimore