Senior Scientist, Biologics Analytical R&D (On-site)

About the role

Join a team dedicated to advancing lifesaving and life-enhancing medicines through exceptional scientific oversight of our company's biologics portfolio from development through commercialization. Grounded in ethics, integrity, transparency, and scientific rigor, we bring together diverse perspectives to deliver transformative medicines.

Responsibilities

• Validate, implement, transfer, and maintain analytical methods supporting clinical material testing and commercialization readiness.
• As a new project lead by collaborating with external stakeholders and managing validation and testing activities for assigned programs across the team.
• Serve as a subject matter expert across biologics programs, products, and analytical platforms.
• Interpret and review analytical data, assess trends, support investigations, deviations, CAPAs, and data-driven technical decisions.
• Execute and oversee GMP release, stability, and in-process analytical testing for biologics drug substance and drug product using established and advanced analytical technologies.
• Provide scientifically sound recommendations to address technical challenges and support decision-making across development stages.
• Support biologics registrations, product launches, and technical troubleshooting.
• Build and manage project timelines and deliverables to drive milestone completion.
• Support audits, inspections, investigations, and CAPA activities through disciplined documentation and inspection-ready practices.
• Ensure analytical activities are conducted in accordance with cGMP expectations, data integrity principles, and applicable regulatory requirements.
• Support instrument qualification activities, including IQ/OQ/PQ, as needed.
• Contribute to strategic initiatives and cross-functional improvement efforts across matrixed teams.
• Author and review technical documentation, including regulatory submissions.
• Support evolving departmental priorities through flexible scientific and operational contributions.

Qualifications

• Ph.D. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with a minimum of 2 years of relevant experience.
• M.S. with a minimum of 3 years of relevant experience; or B.S. with a minimum of 7 years of relevant experience.

Skills

• Strong technical judgment.
• GMP discipline.
• Cross-functional collaboration skills.
• Strong organizational and project management skills.
• Ability to resolve technical issues using innovative, scientifically sound solutions.
• Excellent oral and written communication skills.
• Strong interpersonal and leadership skills.
• Self-motivated, accountable, and results-oriented.
• Willingness to occasionally work evenings, weekends, or irregular hours to support business needs.