What You'll Do:
Lot Disposition Oversight:
- Review, evaluate, and approve all batch records, analytical testing data, and supporting quality documentation prior to lot release.
- Ensure all manufacturing and testing activities are performed in compliance with cGMP and applicable regulatory requirements.
- Oversee lot disposition processes for materials produced internally and by CMOs.
Data Review and Approval:
- Review and assess data generated by CMOs, including in-process and release testing results.
- Evaluate data generated by CTLs and in-house testing to verify compliance with specifications and regulatory expectations.
- Confirm resolution of deviations, investigations, and change controls prior to lot disposition.
- Review stability data, including test records, interim reports, and final stability reports, for accuracy, completeness and compliance
Compliance and Continuous Improvement:
- Ensure timely completion of lot disposition activities to meet clinical and commercial supply timelines.
- Identify process gaps and drive continuous improvement initiatives in quality systems related to lot disposition.
- Support internal and external audits related to lot disposition processes.
Cross-Functional Collaboration:
- Partner with Manufacturing, QC, Supply Chain, and Regulatory Affairs and Process and Assay Development as required to address quality issues impacting lot disposition.
- Provide guidance to internal and external stakeholders on quality standards and regulatory compliance.
About You:
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience.
- Minimum 5 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or related regulated industry, including experience with lot disposition.
- Experience working with CMOs and CTLs in a cGMP environment preferred.
- Strong understanding of cGMP, ICH guidelines, and applicable regulatory requirements.
- Proficient in reviewing manufacturing batch records, analytical data, and quality documentation.
- Excellent attention to detail and ability to make sound quality decisions.
- Strong organizational, problem-solving, and communication skills.
- Ability to work independently and in a cross-functional team environment.
- Proficiency with electronic quality management systems (e.g., MasterControl) is an asset.
Top Skills
What We Do
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
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