We are seeking a highly motivated and experienced QC Stability Lead to join our Quality Control team at Adverum. The QC Stability Lead 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:
- As Lead you will 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.
- Data Analysis and Reporting:
- 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.
- Compliance and Quality Assurance:
- 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.
- Collaboration and Communication:
- 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.
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.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion, and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.
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.
