Part Time R&D Quality Specialist

Our client, a company researching and developing novel gene therapies, is looking for a Part Time R&D Quality Specialist to join their team. You will review and provide quality support on preclinical and nonclinical data generated internally and from partners. 

 

Our ideal candidate should have a background/knowledge in gene therapies or biologics and have knowledge of Analytic Methods.

 

Note: this is a remote, ongoing contract role requiring a time commitment of 20-25 hours/week.

 

Responsibilities:

• Review and provide QA support on incoming data surrounding novel gene therapies used to treat neurodegenerative disorders
• Audit implementation of lab Work Instructions
• Review testing methods and Analytical Development protocols
• Audit nonclinical, non-GLP study reports
• Develop and review standards of procedure related to Quality and R&D
• Work alongside cross-functional groups, including Analytical Development, Process Development, Bioanalytical, and more.

 

Qualifications:

• Advanced degree in biological sciences or related
• At least 5+ years of experience as a Quality Specialist with a focus in gene therapies and/or biologics
• Prior experience in a similar role, reviewing laboratory data, documentation, and reports
• Demonstrated experience with analytical methods used for gene therapy such as qPCR, ddPCR, Potency assays, TCID50, NGS, SDS Page, AUC, ELISA, MSD, Western Blot, etc.
• Thorough knowledge of preclinical, GLP and GMP practices from a technical and regulatory compliance perspective

 

Please submit a resume for immediate consideration.

 

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