Job Summary This is a laboratory testing position with the major responsibilities include daily testing per SOP, protocol-driven non-routine testing, peer data review, writing/revising standard operating procedures, scheduling lab activities, investigating aberrances and providing/implementing compliant solutions, technical writing, and general laboratory maintenance and upkeep. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Technical Expertise:

• Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
• Demonstrates proficiency in moderately complex methods such as ELISA, Cell Culture, Plaque assays, CCIT, KF, pH, etc.
• Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.
• Work with Management to coordinate scheduling of laboratory activities
• Ability to Investigate and determine Root Cause associated with laboratory deviations.
• Executes Change Controls, CAPAs, and Effectiveness Checks
• Executes validation studies; obtain and interpret validation data.
• Maintains laboratory equipment as per established procedure

Laboratory Support (Including Quality Systems):

• Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
• Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
• Uses GMP and scientific expertise to lead internal (department and site) audit activities.
• Performs as supporting personnel and/or acts as lead under guidance of management or higher level scientific personnel.
• May provide guidance to lower level personnel.
• Performs laboratory instrument calibration in accordance with established procedures.
• Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
• May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.

Quality Systems:

• Reviews and Verifies 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.

Problem Solving:

• Works on problems of diverse scope requiring evaluation of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Receives no instruction on routine work, general instructions on new assignments.

Behavior/Cultural Responsibilities:

• Ownership - Actively participate in self-development
• 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 management's assignment of essential functions. Minimum Education, Experience, Skills

• Bachelors or Master's degree in a scientific discipline
• Minimum of 5 years of related experience
• Hands-on experience with one or more assays and instruments: cell-based toxin neutralization assays, animal handling and dosing, and cell culture
• Strong technical and communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Flexible.
• Computer skills (MS Office, JMP statistical software, Visio, MS Project)

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.