Principal Scientist

Overview

Element has an opportunity for a Principal Scientist to join our Eagan MN laboratory which specializes in microbiological testing and analytical support for antimicrobial pharmaceutical medical device and related regulated manufacturing and consumer product industries. The Principal Scientist performs and evaluates both custom and standardized microbiological testing that supports client needs focusing on R&D and lot release for medical device manufacturing. Methods include TOC endotoxin bioburden and general sterility testing reusable device cleanliness and low / high level disinfection; generates data while maintaining a high level of scientific integrity; assists in the review of test results raw data and Certificates of Analysis; The role will lead a team to execute to standard and custom protocols and work creatively with customers to deliver to target acceptance criteria; designs and executes research and development (R&D) projects when implementing new methods or adapting current methods; maintains awareness of advances and changes in the test methodology; effectively communicates with management and others in the company to share information offer ideas and think creatively to effectively solve client testing problems to support registrations of new and novel antimicrobial this role you may also perform sterility and bioburden testing environmental monitoring and method qualifications.

This position plays a key role in executing testing within a cGLP and ISO 17025 environment maintaining data integrity and ensuring results are scientifically sound timely and defensible. The Principal Scientist works closely with internal technical teams and external client partners and contributes directly to maintaining the high standards of quality and reliability that Element is known for.

You can read more about the work out Eagan lab does here : EMT Eagan Lab Page

Responsibilities

• Leads team on sterility testing assays including standard methods and custom methods TOC bioburden endotoxin Cytotoxicity toxicology
• May perform assays including bioburden sterility testing microbial enumeration organism identification endotoxin testing and microbial limits testing.
• Serves as SME in the re-usable medical device space with direct support on protocol and method development in high and low level disinfection cleanliness validation etc.
• Conduct method development qualification verification and validation activities in alignment with industry standards.
• May support environmental monitoring and cleanroom qualification programs including surface air and personnel monitoring.
• Maintain accurate compliant documentation within laboratory information and quality systems.
• Prepare test reports review data and communicate results clearly and professionally to internal and external partners.
• Participate in equipment maintenance calibrations and laboratory housekeeping to ensure safe and compliant operations.
• Assist with client technical transfers and onboarding of new test methods as needed.
• Ability to adapt standard laboratory techniques and tests to meet the demands of specific problems.
• Ability to make complex mathematical computations use statistical techniques in the treatment of data and interpret and apply findings.
• Work as an effective and proactive team-player; understands the importance of supporting the organization customers and other employees.
• Ability to maintain appropriate records for all facets of job.
• Able to use critical thinking logic and reasoning to identify the strengths and weaknesses of alternative solutions conclusions or approaches to problems.
• Able to communicate effectively in writing as appropriate for the needs of the audience.
• Able to manage work time determine priorities seek assistance when necessary and complete projects within deadlines.
• Identifies complex problems and reviewing related information to develop and evaluate options and implement solutions independently.
• Able to plan prioritize coordinate and manage work in a fast-paced environment. Able to work unsupervised make complex level decisions independently and solve problems effectively and creatively.
• Displays high levels of customer service responding promptly and thoroughly to the inquiries and needs of individuals both internal and external to the organization as applicable.
• Understand and maintain confidential nature of customer organization and employee information.
• Show professional knowledge proficiency and initiative in achieving goals and meeting standards

Skills / Qualifications

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Diversity Statement

At Element we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming the worlds most trusted testing partner.

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following : age disability ethnic origin gender marital status race religion responsibility of dependents sexual orientation or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

Required Experience :

Staff IC

Key Skills

Machine Learning,Python,Data Science,AI,R,Research Experience,Sensors,Drug Discovery,Research & Development,Natural Language Processing,Data Analysis Skills,Toxicology Experience

Employment Type : Unclear

Experience : years

Vacancy : 1