Principal Scientist

Element Materials Technology•Eagan, MN

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About The Position

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 products. In 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

Requirements

MS or PhD in Microbiology, Biology, Medical Laboratory Science, or related discipline.
10 years of hands-on microbiology experience in a cGLP, ISO 17025, or regulated laboratory environment.
Working knowledge and direct experience in medical device cleanliness and reprocessing cleaning validations and disinfection validations, sterility, etc.
Demonstrated experience with aseptic technique and/or cleanroom operations.
Strong documentation discipline and familiarity with GxP data integrity expectations.
Ability to manage multiple projects while maintaining focus, accuracy, and compliance.
Effective written and verbal communication skills, including the ability to interpret testing procedures and prepare clear technical documentation.

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