CMC Stability Specialist (Biotechnology, Remote)

Job summary

The CMC Stability Specialist will be part of a dedicated team focused on the stability governance of biologics products, collaborating with various internal and external stakeholders in a global environment. This role involves ensuring compliance with regulatory standards and supporting the biologics pipeline from development to commercialization.

Qualifications

• PhD or MSc in pharmaceutical sciences, chemistry, biochemistry, statistics, or a related field.
• Over 5 years of experience in CMC stability for biologics.
• In-depth knowledge of stability testing for clinical and marketed biologics.
• Familiarity with statistical methods for stability data analysis.
• Strong understanding of ICH guidelines relevant to stability.
• Experience with global regulatory submissions.

Responsibilities

• Serve as a stability expert for biologics pipeline.
• Oversee stability activities at external partners and internal labs.
• Ensure regulatory-compliant stability approaches per ICH guidelines.
• Conduct statistical evaluations of stability data, including trend analysis.
• Author and review CMC sections for regulatory submissions.
• Support interactions with health authorities regarding stability matters.
• Contribute to life cycle management of stability for commercial products.

Skills

• Ability to work in a fast-paced environment with integrity.
• Strong collaboration skills with diverse stakeholders.
• Analytical problem-solving approach.
• Proficiency in IT and software for stability monitoring.
• Effective multitasking and prioritization abilities.

Education

• PhD or MSc in relevant scientific fields.

Tools

• Statistical analysis software and stability monitoring tools.