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 is a laboratory testing position with the major responsibilities being daily testing, quality systems support, and inter-departmental scientific support. Works on complex and varied problems/projects requiring in depth analysis and interpretation.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
- Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers. Testing includes Sterility, Bioburden, endotoxin (gel clot), biological indicator testing.
- Environmental Monitoring, Utilities and Gas sampling and testing.
- Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement, Microbial Limits testing, growth promotion.
- Executes validation studies, obtain and interpret validation data following microbial guidance documents.
- Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs.
- Laboratory Support (Including Quality Systems):
- Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
- Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory.
- Uses GMP and scientific expertise to lead internal (department and site) audit activities.
- Mentor and provide guidance to junior personnel.
- Performs laboratory instrument calibration in accordance with established procedures.
- Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate
- Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
- Ensure critical QC metrics are consistently met for product turnaround times.
- Peer Reviews and Verification of QC data.
- Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
- Author laboratory investigations and non-conformance.
- Supports CAPA and change control through participation in project planning and collaboration
- Works on problems of diverse scope requiring evaluation of identifiable factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Receives minimal instruction on routine work, general instructions on new assignments.
- Ownership Actively participate in self-development (IPMP)
- Accountability Follow through on commitments, Situational Leadership or additional accountability tools
- Detail oriented Able to complete required tasks and associated documentation with minimal error
- Adaptability Maintain positive attitude in a changing work environment
- Communication Effectively communicate with all levels of manufacturing and support staff
- Actively participate in department / level meetings
- Escalate issues through the proper channels
- Live the Core Values
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 managements assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor or Master Degree in an applied science (microbiology preferred).
- 2 - 5 years of experience preferred, or equivalent level of skill and experience.
- Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.
- Hands-on experience with one or more microbiology techniques: membrane filtration, inoculation (brothgar), serial dilutions, biochemical tests, microbial identification, enumeration, environmental monitoring.
- Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
- An understanding of cGMP, CFR, USP, and aseptic processing guidelines is required.
- Require good written and verbal communication skills, good team work skills
- Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required.
- May require work on weekends, and nights.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.ABOUT EMERGENT
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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
- 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.