We are seeking a highly motivated and experienced QC Stability Manager to join our Quality Control team at Adverum. The QC Stability Manager will be responsible for overseeing the stability program to ensure the safety, efficacy, and quality of our products throughout their shelf life. This role involves managing stability studies, analyzing data, and ensuring compliance with regulatory requirements.
What you'll do:
- Stability Program Management:
- Develop, implement, and manage the stability program in compliance with regulatory guidelines and company SOPs.
- Oversee the design and execution of stability studies, including protocol development, sample management, and data collection.
- Ensure timely initiation, monitoring, and completion of stability studies.
- Identify opportunities for process improvements in the stability program.
- Implement best practices and innovative solutions to enhance the efficiency and effectiveness of stability studies.
- Stay current with industry trends, regulatory updates, and scientific advancements related to stability testing.
- Analyze stability data to assess product performance and identify trends.
- Prepare comprehensive stability reports and summaries for regulatory submissions and internal reviews.
- Ensure accurate and timely documentation and reporting of stability data.
- Ensure all stability studies comply with GMP, ICH guidelines, and other relevant regulatory requirements.
- Conduct regular audits of stability studies and processes to maintain high-quality standards.
- Implement corrective and preventive actions (CAPAs) as needed to address any deviations or non-conformances.
- Work closely with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to ensure alignment and support for stability studies.
- Serve as the primary point of contact for stability-related inquiries and issues.
- Communicate stability study results and recommendations to stakeholders and senior management.
Data Analysis and Reporting:
Compliance and Quality Assurance:
Collaboration and Communication:
About you:
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field (Master’s or Ph.D. preferred).
- Minimum of 8-10 years of experience in a Quality Control or Stability role within the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP, ICH guidelines, and regulatory requirements for stability testing.
- Experience with stability program management, including protocol development, data analysis, and reporting.
- Excellent analytical, organizational, and problem-solving skills.
- Strong attention to detail and the ability to manage multiple tasks simultaneously.
- Effective communication and interpersonal skills to work collaboratively with cross-functional teams.
- Proficiency in using laboratory information management systems (LIMS) and other relevant software.
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.
