CMC Stability Specialist (Biotechnology, Remote)

Job summary

The CMC Stability Specialist will be a key member of the CMC Stability team, responsible for overseeing stability governance of biologics products. This role involves collaboration with various departments and external partners in a dynamic, international setting.

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, adhering to industry best practices.
• Familiarity with statistical methods for stability data analysis.
• Strong understanding of ICH guidelines, including Q1A–Q1E, Q5C, and Q6B.
• Experience in global regulatory submissions.

Responsibilities

• Serve as a stability expert for the biologics pipeline.
• Oversee stability activities at external partners and internal labs.
• Ensure compliance with ICH guidelines in stability approaches.
• 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 support for commercial products.

Skills

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

Education

• Advanced degree in a relevant scientific field is required.

Tools

• Familiarity with statistical analysis software and regulatory submission tools.