Eurofins Lancaster Laboratories

Principal Scientist- Med Device Mircobiology

Eurofins Lancaster Laboratories • $110K — $130K *
Lancaster, PA 17603In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in biology or microbiology
  • Minimum 5 years of laboratory experience
  • Working knowledge of Electronic Lab Notebook (ELN) and Lab Information Management System (LIMS)
  • Solid familiarity with regulatory standards (GMP, GLP, USP, ISO, AATCC, etc.)
  • Prior experience in microbiology, particularly antimicrobial and reprocessing
  • Strong technical writing skills, including experience with investigations
  • Authorization to work in the US indefinitely without sponsorship

Responsibilities

  • Serve as a technical expert for audits and client interactions
  • Provide scientific leadership on medical device reprocessing programs
  • Support method development, validation, and improvement initiatives
  • Communicate complex technical information to various stakeholders

Benefits

  • Comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
Full Job Description
Job Description

Key Responsibilities
  • Serve as a technical subject matter expert and resource for internal and external audits, client interactions, and business development activities.
  • Provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs.
  • Support method development, validation, troubleshooting, and continuous improvement initiatives.
  • Communicate complex technical information effectively to clients, regulatory bodies, and internal stakeholders.

Core Competencies
  • Exceptional collaboration and interpersonal skills, with the ability to build strong partnerships and work effectively across cross-functional teams.
  • Strong analytical, problem-solving, and decision-making abilities.
  • Ability to influence stakeholders and provide technical leadership in a fast-paced, regulated environment.

Required Experience
  • Extensive experience in medical device reprocessing, including cleaning, disinfection, and sterilization processes.
  • Strong background in microbiological testing, including antimicrobial efficacy, sterility, sub-visible particle analysis, bioburden, microbial limits testing (MLT), container closure integrity testing (CCIT), and endotoxin testing, with recognized subject matter expertise in at least one testing discipline.
  • Experience working in controlled environments and cleanroom operations.
  • Comprehensive understanding of the medical device lifecycle, from development through commercialization and post-market support.
  • Demonstrated expertise in designing, executing, and evaluating scientific studies and test methods.
  • Proven ability to interpret pharmacopeial requirements, industry standards, and regulatory guidance documents, and assess emerging methodologies and technologies for applicability.
  • Strong technical writing skills with experience authoring protocols, reports, investigations, and other scientific documentation.


Qualifications

Minimum Qualifications

  • Bachelor's degree in biology or microbiology
  • Minimum 5 years of laboratory experience
  • Working knowledge of Electronic Lab Notebook (ELN), Lab Information Management System (LIMS)
  • Solid familiarity and experience with regulatory and accreditation standards (GMP, GLP, USP, ISO, AATCC, etc).
  • Prior experience working in microbiology - especially antimicrobial and reprocessing
  • Strong leadership
  • Excellent planning, organizational, and multitasking skills.
  • Strong technical writing skills including experience with investigations.
  • Familiarity with Lean, Six Sigma, or similar process improvement methodologies
  • Experience with onboarding new instrumentation, including performing/reviewing IQ/OQ/PQ data or qualifications
  • Authorization to work in the US indefinitely without restriction or sponsorship


Additional Information

Position is full-time position, Monday - Friday 8:00am - 5:00pm with additional hours as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. Up to 25% travel may be required.

Excellent full time benefits including
  • Comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays

About Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
Learn more about Eurofins Lancaster Laboratories
Size
12,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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