CMC QA Asssociate

A pharmaceutical company in Massachusetts is currently seeking an experienced professional to join their staff as their new CMC QA Associate. Reporting to the Senior Director of CMC QA, the CMC QA Associate will be responsible for supporting the cross functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc.) to confirm the appropriate quality as well as compliant controls are in place for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.

This is a hybrid role in Bedford, Mass.

• Provide quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO).
• Support review and approval of process characterization studies and associated report.
• Provide quality oversight of process performance qualifications and associated studies.
• Review and approve process validation protocols and reports (i.e., Mixing validation, hold studies, extractable and leachable, impurity, column storage etc.).
• Review and approve tech transfer plan, report, and associated deliverables.
• Author and review of regulatory submissions and responses. Review and approve batch records, CC, deviations, and other quality systems.
• Support batch disposition and release.
• Perform other duties, as needed.

• 7+ years of experience in a GMP Biopharmaceutical Manufacturing environment in Technical Operations and/or Quality.
• Bachelor's Degree.
• Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice.
• Experience supporting authoring/ reviewing/ approving technical studies.
• Experience leading and participating in investigations into manufacturing and analytical deviations and determination of product impact, root cause, and corrective and preventative actions.
• Experience with performing technical assessment of changes for potential impact to qualification/ validation of processes, equipment, utilities, facilities and systems.
• Experience in all phases of biologics, gene therapy, and/ or cell therapy drug development.
• Expert knowledge of cGMP compliance regulations and industry practices for US/Ex-US.

• Bachelor's Degree in Biotechnology, Biological / Physical Sciences, and/or Engineering.

Entry level

Full-time

Science

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