About The Position

This position is responsible for supporting analytical method transfer and validation activities to ensure robust and compliant testing of biologic products. The role requires strong technical expertise and attention to regulatory requirements in a GMP-compliant environment. This role is onsite in Sanford, NC. There are no public transportation options to the site. Ability to support outside standard hours may be needed.

Requirements

  • BS in Chemistry or similar field with a minimum of 2 years of experience working in a laboratory environment.
  • Experience working with proteins or carbohydrates.
  • Experience working in a Good Manufacturing Practices also cGMP environment
  • Experience working with analytical standards, reagents, and laboratory instruments
  • Strong pipetting skills
  • HPLC and Empower 3 experience
  • Familiarity with USP, EU guidelines
  • Effective oral and written communication
  • Strong problem-solving skills
  • Excellent oral and written communication skills as well as strong computer skills
  • Must be organized, self-motivated, and capable of working independently or in a collaborative environment.
  • Authorization to work in the United States indefinitely without restrictions or sponsorship

Responsibilities

  • Collaborate with internal and external partners to execute method qualification, validation protocols, and transfer documentation
  • Data analysis, protocol/report generation, and troubleshooting analytical techniques such as HPLC, CE, and ELISA

Benefits

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