QC Scientist Analytical Method Validation

Genezen; Fishers (IN); On-site; USD 85,000 - 159,000; Full time

Job summary

Genezen is seeking a QC Scientist in Analytical Method Validation to play a crucial role in the Quality Control Technical Services department. This entry-level position involves the optimization and validation of analytical methods for gene therapy products while ensuring compliance with FDA and EMA guidelines. Candidates should possess a strong foundation in analytical techniques and the ability to thrive in a collaborative and regulated environment.

Qualifications

• Familiarity with FDA and EMA guidance.
• Ability to perform statistical analyses.
• Experience with cGMP operations.

Responsibilities

• Collaborate with teams for validation of analytical methods.
• Write protocols and reports for method validation.
• Support monitoring and troubleshooting of analytical methods.

Skills

Collaboration

Analytical Skills

Leadership

Adaptability

Quality Assurance

Job description

QC Scientist Analytical Method Validation

3 days ago Be among the first 25 applicants

The QC Scientist Analytical Method Validation is a key role within the Quality Control Technical Services (QCTS) department at Genezen. The individual will collaborate with analytical development, quality control, and quality assurance teams to transfer and validate next generation analytical procedures for testing viral vectors, cell banks, and gene therapy products. Responsibilities include optimization, qualification, transfer and validation of analytical methods under cGMP production, writing protocols and reports, performing statistical analyses, supporting monitoring of analytical method performance, data trending, supporting cGMP operations, presenting to cross-functional teams, and providing subject matter expertise in product quality attribute methods relevant to gene therapy. The role requires familiarity with FDA and EMA guidance, quality systems, and the ability to work in a fast-paced environment with leadership and collaboration skills. Additional duties include maintaining laboratory procedures, performing routine/non-routine testing, documentation compliance, troubleshooting, and training other QC Analysts. The position requires adaptability, a criminal background check, and adherence to company policies and regulatory guidelines. Genezen operates two locations in Fishers, Indiana and Lexington, Massachusetts, and is an Equal Opportunity Employer participating in EVerify. Visa sponsorship is not available.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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