Biologic Method Transfer & Validation Scientist (GMP)

Eurofins PSS Insourcing Solutions

Sanford (NC)

On-site

USD 65,000 - 90,000

Full time

2 days ago
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Benefits offered by this job

Medical, dental, and vision insurance
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions in Sanford, NC is seeking a Laboratory Analyst to support analytical method transfer and validation of biologic products in a GMP environment.

You will collaborate with internal and external partners to execute method qualification, validation protocols, and transfer documentation, and perform data analysis, protocol/report generation, and troubleshooting of analytical techniques such as HPLC, CE, and ELISA.

Qualifications

  • BS in Chemistry or similar field; minimum 2 years in a lab environment.
  • Experience working with proteins or carbohydrates.
  • Experience in GMP/cGMP environment.
  • Experience with analytical standards, reagents and lab instruments.
  • Strong pipetting skills.
  • HPLC and Empower 3 experience.
  • Familiarity with USP or EU guidelines.
  • Effective oral and written communication; strong problem-solving skills.
  • Organized, self-motivated and able to work independently or in a team.
  • Authorization to work in the United States without sponsorship.

Responsibilities

  • Support analytical method transfer and validation activities in a GMP-compliant environment.
  • Collaborate with internal and external partners to execute method qualification, validation protocols and transfer documentation.
  • Perform data analysis, protocol/report generation and troubleshooting analytical techniques (HPLC, CE, ELISA).

Skills

Data analysis
Protocol / report generation
Regulatory compliance
Oral and written communication
Problem solving
Computer skills
Pipetting
Independent work

Education

BS in Chemistry or similar field

Tools

Empower 3
HPLC
CE
ELISA

Job description

Eurofins USA PSS Insourcing Solutions in Sanford, NC is seeking a Laboratory Analyst to support analytical method transfer and validation of biologic products in a GMP environment.

You will collaborate with internal and external partners to execute method qualification, validation protocols, and transfer documentation, and perform data analysis, protocol/report generation, and troubleshooting of analytical techniques such as HPLC, CE, and ELISA.

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