About The Position

This position supports analytical method transfer and validation activities to ensure robust and compliant testing of biologic products. The scientist collaborates with internal and external partners to execute method qualification and validation protocols and prepare transfer documentation. The role also involves data analysis, protocol and report generation, and troubleshooting analytical techniques such as HPLC, CE, ELISA, and PCR. Strong technical expertise and attention to regulatory requirements are needed in a GMP-compliant environment. The role is onsite in Sanford, North Carolina. The schedule is Sunday through Wednesday, 7 a.m. to 7 p.m.; support outside standard hours may be needed. There are no public transportation options to the site, and candidates within commuting distance are encouraged to apply.

Requirements

  • Bachelor of Science in Chemistry or a similar field.
  • At least 2 years of experience working in a laboratory environment.
  • Strong pipetting experience and skills.
  • Experience working with proteins or carbohydrates.
  • Experience working in a Good Manufacturing Practices (GMP/cGMP) environment.
  • Experience working with analytical standards, reagents, and laboratory instruments.
  • HPLC and Empower 3 experience.
  • Familiarity with USP and EU guidelines.
  • Effective oral and written communication skills.
  • Strong problem-solving skills and computer skills.
  • Organized, self-motivated, and able to work independently or collaboratively.
  • Authorization to work indefinitely in the United States without restrictions or sponsorship.

Responsibilities

  • Support analytical method transfer and validation activities for biologic product testing.
  • Collaborate with internal and external partners to execute method qualification and validation protocols and prepare transfer documentation.
  • Analyze data and generate protocols and reports.
  • Troubleshoot analytical techniques, including HPLC, CE, ELISA, and PCR.

Benefits

  • Comprehensive medical coverage
  • Dental insurance options
  • Vision insurance options
  • Life insurance
  • Disability insurance
  • 401(k) with company match
  • Paid vacation
  • Paid holidays
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