Senior Scientist, Biologics Analytical Development

About the role

We are seeking a Senior Scientist to lead stability programs for biologic drug substances and drug products throughout clinical development. This role will be responsible for developing stability strategies, overseeing external testing partners, analyzing stability data, and supporting shelf-life, retest period, and regulatory decisions.The ideal candidate will have extensive experience managing stability programs, strong statistical analysis capabilities, and a thorough understanding of regulatory expectations for biologic products.

Responsibilities

• Develop and execute stability strategies supporting product development, manufacturing, clinical supply, and regulatory objectives.
• Define storage conditions, testing schedules, analytical panels, acceptance criteria, and study durations.
• Oversee stability studies conducted by external laboratories and manufacturing partners.
• Analyze and trend stability data to assess degradation, variability, product quality, and long-term performance.
• Utilize JMP for statistical analysis, shelf-life projections, retest period assessments, and stability evaluations.
• Identify and evaluate OOT results, OOS results, emerging trends, and potential product-quality risks.
• Support establishment of shelf life, expiration dating, and retest periods.
• Author and review stability protocols, reports, specifications, SOPs, technical documents, and regulatory submissions.
• Support investigations, deviations, CAPAs, change controls, and temperature excursion assessments.
• Collaborate with cross-functional teams and drive continuous improvement of stability processes and external partner performance.

Qualifications

• BS/BA, MS/MA, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
• Approximately: 11+ years of relevant experience with a Bachelor's degree
• 9+ years with a Master's degree
• 5+ years with a PhD
• Extensive experience managing stability programs within the pharmaceutical, biotechnology, or related industry.
• Strong understanding of biologic stability, degradation pathways, accelerated studies, shelf-life determination, and retest period assignment.
• Strong knowledge of ICH stability guidelines and global regulatory requirements.
• Proficiency with JMP for statistical analysis, stability trending, regression modeling, and shelf-life assessments.
• Experience interpreting long-term stability data and identifying quality risks and trends.
• Experience overseeing external laboratories, manufacturing organizations, or service providers.
• Knowledge of cGMP requirements, quality systems, CAPAs, deviations, OOS, and OOT investigations.
• Excellent technical writing, communication, and project management skills.

Skills

• Experience supporting regulatory submissions and health authority interactions.
• Experience developing stability strategies for late-stage development or commercialization programs.
• Experience evaluating temperature excursions and product impact assessments.
• Experience working within regulated development and manufacturing environments.

Benefits

Full-time employees are also eligible for benefits options such as:

• health coverage
• life insurance
• disability insurance
• 401k benefits