Analytical Validation Expert in Gene Therapy

5 days ago


Lexington, Kentucky, United States Genezen Full time
Unlock a Career in Gene Therapy

We are seeking an experienced Analytical Validation Expert to join our team at Genezen, a pioneering gene therapy company. This is an exceptional opportunity for a skilled professional to contribute to the development of innovative treatments and make a meaningful impact on patients' lives.

About Genezen:

Genezen is a fast-growing company dedicated to advancing gene therapy research and development. Our mission is to deliver high-quality treatments that transform the lives of individuals affected by genetic diseases. We offer a collaborative and dynamic work environment that fosters innovation, teamwork, and professional growth.

Job Summary:

The Analytical Validation Expert will be responsible for developing, validating, and transferring analytical methods associated with cGMP production. This includes optimizing, qualifying, and validating next-generation analytical procedures for testing viral vectors, cell banks, and gene therapy products. The successful candidate will collaborate with cross-functional teams, including analytical development, quality control, and quality assurance.

Key Responsibilities:

  • Develop and validate analytical methods for cGMP production
  • Optimize and qualify next-generation analytical procedures
  • Transfer analytical methods between departments and facilities
  • Collaborate with cross-functional teams to ensure compliance with regulatory guidelines and company policies

Requirements:

To succeed in this role, you will need:

  • Bachelor's or Master's degree in Chemistry, Biochemistry, or a related Life Science field
  • Minimum 6 years of experience in analytical laboratory work, preferably in a GLP/cGMP environment
  • Strong understanding of quality systems requirements and industry standards
  • Excellent communication and collaboration skills
  • Ability to thrive in a fast-paced, dynamic environment

Compensation:

We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience, plus benefits, including paid vacation days, health insurance, and a 401(k) plan.

Why Choose Genezen?

At Genezen, we value our employees' contributions and offer a range of benefits to support their well-being and career growth. Join our team and become part of a dynamic organization that is shaping the future of gene therapy.



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