Job Summary

This is a laboratory testing position with the major responsibilities include maintain testing process optimization, implementing new microbiology initiatives as needed, quality systems support, and inter-departmental scientific support. The position also supports daily environmental/utility and microbiology testing as needed. Works on complex and varied problems/projects requiring in depth analysis and interpretation.

Responsibilities

Technical Expertise:

o Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
o 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), growth promotion, biological indicator testing.
o Environmental Monitoring, Utilities and Gas sampling and testing.
o Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement, Microbial Limits testing, growth promotion.
o Executes validation studies, obtain and interpret validation data following microbial guidance documents.
o Coordinates and processes departmental change controls
o Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs

Laboratory Support (Including Quality Systems):

o Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
o Compiles and analyzes EM/Utility Data and write Quarterly/Annual Reports
o Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory.
o Uses GMP and scientific expertise to lead internal (department and site) audit activities.
o Mentor and provide guidance to junior personnel.
o Performs laboratory instrument calibration in accordance with established procedures.
o Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate
o Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
o Ensure critical QC metrics are consistently met for product turnaround times.

Quality Systems:

o Peer Reviews and Verification of QC data.
o Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
o Author laboratory investigations and non-conformance.
o Supports CAPA and change control through participation in project planning and collaboration.

Problem Solving:

o Works on problems of diverse scope requiring evaluation of identifiable factors.
o Exercises judgment within defined procedures and practices to determine appropriate action.
o Receives minimal instruction on routine work, general instructions on new assignments.

Behavior/Cultural Responsibilities:

o Ownership - Actively participate in self-development
o Accountability - Follow through on commitments, Situational Leadership or additional accountability tools
o Detail oriented - Able to complete required tasks and associated documentation with minimal error
o Adaptability - Maintain positive attitude in a changing work environment
o Communication - Effectively communicate with all levels of manufacturing and support staff
o Actively participate in department / level meetings
o Escalate issues through the proper channels
o Live the Core Values

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
• Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
• Bachelor or Master Degree in an applied science (microbiology preferred).
• 5 - 7 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 (broth/agar), 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.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $84,000 to 101,700. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

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.