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Responsibilities Include

• GMP Compliance: ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP.
• Batch Review / Release: Support clinical batch review and release by performing appropriate quality control review of all QC data generated by third parties. Identify issues of non-compliance, working directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner.
• Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed.
• Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed.
• Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QA support of all activities.
• Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner.
• Training and Education: Assist in providing training and guidance to PD personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures.
• Risk Management: Identify and assess potential risks related to GMP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues.
• Continuous Improvement: Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality.
• Communication: Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements to Quality Management.

Required Qualifications

• Bachelor’s degree in a scientific discipline; Advanced degree preferred
• Minimum of 5 years hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
• Minimum of 2 years hands-on experience in GXP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
• Prior clinical batch review experience preferred
• Experience interacting with external testing laboratories preferred
• Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
• Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently in order to appropriately prioritize work.
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in a startup industrial setting is preferred.

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