Stability strategy Lead
1 month ago
The Stability Strategy Lead for Large Molecules will be responsible for developing and implementing stability strategies for large molecule biopharmaceuticals, ensuring product quality and compliance throughout the product lifecycle. This role requires a deep understanding of the stability of biological products, regulatory requirements, and the ability to lead cross-functional teams to achieve stability objectives.
Key Responsibilities:
- Stability Strategy Development:
- Design and implement stability protocols for large molecule products, including monoclonal antibodies, recombinant proteins, and other biologics.
- Develop comprehensive stability study plans in compliance with ICH guidelines and regulatory requirements.
- Identify critical quality attributes and potential degradation pathways for large molecules.
- Project Management:
- Lead cross-functional teams to execute stability studies, ensuring timely completion and adherence to project timelines.
- Coordinate with analytical, formulation, regulatory, and manufacturing teams to ensure alignment and integration of stability data.
- Data Analysis and Interpretation:
- Analyze stability data to assess product shelf life and support regulatory submissions.
- Identify trends, anomalies, and potential issues, providing scientifically sound recommendations for product improvement.
- Regulatory Compliance:
- Ensure all stability studies are conducted in compliance with global regulatory requirements.
- Prepare and review stability sections for regulatory submissions, including INDs, BLAs, and MAAs.
- Stay current with evolving regulatory guidelines and industry best practices related to stability of biologics.
- Quality Assurance:
- Develop and maintain stability-related SOPs, protocols, and reports.
- Conduct risk assessments and implement corrective actions to address stability-related issues.
- Ensure proper documentation and data integrity in all stability activities.
- Innovation and Continuous Improvement:
- Explore and implement innovative approaches and technologies for stability testing.
- Continuously evaluate and improve stability processes to enhance efficiency and robustness.
Qualifications:
- Ph.D. or M.Sc. in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of experience in biopharmaceutical stability studies, with a focus on large molecules.
- In-depth knowledge of stability testing methodologies, regulatory guidelines (ICH, FDA, EMA), and quality systems.
- Proven track record of leading stability programs and managing cross-functional teams.
- Strong analytical and problem-solving skills, with proficiency in data analysis software.
- Excellent communication and presentation skills, with the ability to clearly convey complex scientific concepts to diverse audiences.
- Detail-oriented with a commitment to scientific rigor and regulatory compliance.
Preferred Qualifications:
- Experience with statistical analysis and stability modeling.
- Familiarity with CMC regulatory requirements for biologics.
- Knowledge of new and emerging technologies in stability testing (e.g., high-throughput screening, predictive modeling).
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