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.
I. JOB SUMMARY
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.
II. ESSENTIAL FUNCTIONS
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- 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.
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.