Principal Scientist Stability

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Principal Scientist Stability to lead stability strategies for commercial biologics. You will oversee stability programs, author study protocols, review reports and filings, and support regulatory inspections.

The role requires 8+ years in pharmaceutical stability, deep knowledge of ICH guidelines and cGMP, and experience with global regulatory requirements. Strong data analysis and collaboration skills are essential.

Qualifications

• Bachelor's degree in a relevant field and 8+ years in pharmaceutical stability or related areas.
• Strong knowledge of ICH stability guidelines (Q1A, Q5C) and cGMP regulations.
• Experience with global regulatory requirements (US/EU/ROW) and data analysis.
• Familiarity with analytical/microbiology methods and stability data systems.

Responsibilities

• Lead stability program development and maintenance for large molecule biologics.
• Author/study protocols and review stability reports and regulatory filings.
• Support change controls and represent stability in cross-functional projects.
• Manage stability data analysis, investigations, and regulatory responses.
• Collaborate with transfer teams and support health authority inspections.
• Streamline stability operations and regulatory interactions.

Skills

Stability program management

Regulatory knowledge

Data analysis

ICH Q1A/Q5C knowledge

Education

Bachelor's degree in Chemistry, Biology, Microbiology or similar

Tools

Statistics software

Stability management systems

Job description

Role: Principal Scientist Stability overseeing stability strategies and programs for commercial large molecule biologics, including Drug Substances and Drug Products.

Responsibilities: lead stability program development and maintenance, author/study protocols, review stability reports and regulatory filings, support change controls, and represent stability in cross-functional projects. Manage stability data analysis, investigations, and stability-related regulatory responses. Collaborate with transfer teams, support health authority inspections, and streamline stability operations.

Qualifications: B.S. in Chemistry, Biology, Microbiology or similar; 8+ years in pharmaceutical stability or related fields. Expertise in ICH stability guidelines (Q1A, Q5C), cGMP regulations, and global regulatory requirements (US/EU/ROW). Knowledge of analytical/microbiology methods, stability data analysis using statistics software, and stability management systems.

Preferred: experience with biologics, post-approval stability, and external service providers.

High-value: biologics, large molecules, post-approval stability, global supply chain, regulatory submissions, and inspections.

Work setup: not explicitly stated.