The successful candidate will provide quality oversight to gene therapy CMC manufacturing activities. You will support the tech transfer, manufacturing, testing and packing of products for clinical use. You will provide routine review of documentation including batch records, testing data, and investigations to ensure that high quality GMP-compliant products are delivered to patients.
- Review master and executed batch records for bulk drug substance, drug product, and packaged clinical trial material
- Contribute to and support review investigations (deviations, laboratory investigations)
- Review analytical in-process, release, and stability data
- Review equipment and/or process change controls
- Review and approve equipment records including registration, qualification, and maintenance forms, as assigned
- Contribute to and review regulatory filing documents as needed
- Review or contribute to risk assessments
- Drive a quality-oriented culture throughout the organization
- Contribute to wider organizational goals and/or activities as assigned
- Act as liaison with contract manufacturing/testing organizations (CMO/CTO)
- Support operations with QA on the floor oversight at CMO locations
- Potential to support internal or external audits on an occasional basis
- Act as Quality representative on internal and external cross functional project teams
- Ability to travel up to 10-20% with potential for international travel
Skills and qualifications:
- Minimum of 4 years of GMP or CMC-related experience (Quality, Operations, Analytical, Process Development) in gene therapy / cellular therapy/biopharma / biologics / pharmaceutical organization(s)
- Minimum of a Bachelor’s degree in scientific discipline
- Experience in GMP record review including investigations, change control, validation, and risk assessment
- Basic understanding and awareness of cGMP regulations (21 CFR 210/211, ICH Q7A, etc.) and their practical application to pharmaceutical and biologics development and manufacturing
- Basic understanding of biologics manufacturing process.
- Ability to follow assignments through to completion per assigned due dates.
- Quality Assurance experience preferred