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Scientist II

Contract: North Chicago, Illinois, US

Salary Range: 48.00 - 54.00 | Per Hour

Job Code: 363596

End Date: 2025-08-10

Days Left: 5 days, 15 hours left

Position Details: 
Industry: Pharmaceutical 
Position Title: Scientist II
Duration: 12 months (Possible extensions)
Location: North Chicago, IL 60064
Pay: $48 - $54/hour 
 
Job Description:
Position Summary
  • Provide global microbiology support across the network, specifically in the area of medical device combination products.
  • Responsibilities include consulting, troubleshooting, and providing scientific guidance.
  • Write and review regulatory submissions for the FDA, EMEA, and global markets.
  • Review investigation reports and contribute to validation activities.
Key Technical Requirements
  • Microbiology Background – preferably from a manufacturing facility.
Experience with:
    • Sterility assurance or sterilization modalities (required)
    • Sterilization methods: moist heat, dry heat, gamma radiation, electron beam (preferred)
    • Microbiological test methods: USP <51>, <61>, <71>, <85>, and equivalent chapters from European and Japanese pharmacopeias
    • ISO standards related to sterilization and microbiological testing
    • Biological indicators (nice to have)
  • Microbiology techniques, method writing, validation, and troubleshooting skills are essential.
  • Regulatory & Documentation Responsibilities
  • Write validated methods and regulatory documentation
  • Prepare regulatory submissions to FDA, EMEA, and other global agencies
  • Collaborate with Subject Matter Experts (SMEs) for validation projects
Day-to-Day Activities
  • Manage assigned microbiology projects
  • Author and validate microbiology testing methods
  • Work closely with SMEs and internal teams for troubleshooting and documentation
  • Provide scientific input for investigations and submissions
  • Preferred Qualifications
  • Master’s degree in Microbiology or a related field with relevant industry experience is preferred
  • PhD with over 5 years of experience is considered overqualified
Soft Skills
  • Strong time management and ability to prioritize tasks
  • Excellent communication and collaboration skills
  • Ability to work in a fast-paced, regulated environment
 
Job Requirement
  • Microbiology
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Himanshu Singh
  • himanshu.ksingh@collabera.com
Apply Now
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