Lead Analytical Method Validation Scientist (QC)

Genezenlabs; Lexington (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Healthcare plans

Job summary

Genezenlabs in Lexington, MA, seeks a QC Senior/Principal Scientist for Analytical Method Validation. This pivotal role involves collaborating with clients and teams to validate analytical procedures for gene therapy products while ensuring compliance with regulatory guidelines.

A successful candidate will have a strong background in analytical method validation, leadership skills, and a Ph.D or MS in Molecular Biology/Biochemistry or a related field. The position offers a unique opportunity to contribute to the growing gene therapy sector and enhance quality control methods.

Qualifications

• Minimum 8 years of analytical laboratory experience in GLP/cGMP environment.
• Proven experience with analytical method validations.
• Understanding of QC instrument qualification.

Responsibilities

• Lead transfer and validate analytical procedures for viral vectors testing.
• Perform statistical analyses during validation studies.
• Present critical analytical issues to cross-functional teams.

Skills

Analytical method validation

Leadership

Statistical analysis

Collaboration

Communication skills

Education

Ph.D or MS in Molecular Biology/Biochemistry or related Life Sciences

Tools

HPLC

ddPCR/qPCR

ELISA

Minitab

Job description

Genezenlabs in Lexington, MA, seeks a QC Senior/Principal Scientist for Analytical Method Validation. This pivotal role involves collaborating with clients and teams to validate analytical procedures for gene therapy products while ensuring compliance with regulatory guidelines.

A successful candidate will have a strong background in analytical method validation, leadership skills, and a Ph.D or MS in Molecular Biology/Biochemistry or a related field. The position offers a unique opportunity to contribute to the growing gene therapy sector and enhance quality control methods.