Principal Scientist (Residual Impurities)

Role Summary

The Principal Scientist is a technical and strategic leader responsible for method development, qualification, transfer, and lifecycle management of residual impurity assays for biopharmaceutical products including monoclonal antibodies (mAbs), bispecifics, and antibody-drug conjugates (ADCs). This individual thrives in a cross-functional, fast-paced, and collaborative environment, applying strong troubleshooting ability, scientific rigor, and a results-driven mindset to support programs from early development through commercialization. The role demands high accountability, proactive planning, and timely execution of deliverables. The Principal Scientist will supervise and mentor team members while serving as a subject matter expert in residual impurity testing across Biopharmaceutical Development (BPD) and CMC teams.

Responsibilities

• Lead the development of fit-for-purpose and robust residual impurity assays (e.g., HCP, DNA, Protein, Enzyme, Surfactant etc.) to support biologic product development and release.
• Provide technical leadership and hands-on troubleshooting for analytical methods and instrumentation to resolve issues efficiently and maintain method robustness.
• Own and drive method lifecycle activities including development, qualification, transfer to QC, and support method validation aligned with ICH and regulatory expectations.
• Ensure on-time delivery of analytical method development and testing support for process development, process characterization, analytical comparability, and CQA assessment efforts.
• Manage project timelines for impurity analysis and proactively communicate risks, progress, and mitigation strategies to stakeholders.
• Collaborate with CMC teams and Regulatory Affairs to develop residual impurity control strategies, specifications, and regulatory submissions.
• Manage vendor activities and oversee outsourced work including critical reagents, HCP coverage analysis, and CRO support.
• Lead implementation of new technologies and data-driven approaches to improve throughput and sensitivity of impurity assays.
• Author and/or review SOPs, technical protocols and reports, and regulatory filings.
• Foster a high-performance culture by coaching and mentoring scientists, promoting scientific excellence, accountability, and ownership.
• Present findings and strategies at internal cross-functional meetings, technical forums, and external conferences.
• Participate in industry consortia on relevant topics and align internal strategies with industry practice.

Qualifications

• Education & Experience
• Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or related discipline with 6+ years of related industry experience, including 5+ years on residual impurity method development;
• or Master‚Äôs degree with 12+ years of related industry experience;
• or Bachelor‚Äôs degree with 14+ years of related industry experience
• 2+ years of people management experience with demonstrated ability to coach, develop and motivate high-performing teams
• Prior experience in preparing analytical sections of IND, BLA and regulatory responses.

Knowledge, Skills And Abilities

• Deep knowledge of residual impurity assay development (e.g. ELISA for residual protein, qPCR for DNA)
• Excellent troubleshooting and problem-solving skills, with a systematic, data-driven approach to resolving technical challenges
• Strong sense of accountability and ownership; consistently delivers to project goals and regulatory milestones
• Ability to manage multiple projects and priorities in a dynamic, cross-functional environment
• Skilled in stakeholder management, with clear, proactive, and collaborative communication style
• Strong technical writing skills and attention to detail in documentation and data review
• Experience mentoring and developing scientific staff; promotes open communication and teamwork
• Solid understanding of CMC strategy, regulatory expectations, and phase appropriate analytical requirements
• Strong track record of independent troubleshooting, root cause investigation, and method remediation for impurity assays
• Proven success in delivering high-quality results on time, even under changing priorities and compressed timelines.
• Demonstrated leadership and influence in cross-functional matrix environments

Preferred Qualifications

• Familiarity with potency assays, physiochemical assays and other characterization assays
• Knowledge in novel techniques on detecting and analyzing residual impurities
• Strong publication record and external scientific presence
• Experience in fostering partnership with clients through CDMO service

Supervisory Responsibilities

Yes. This role may supervise Associate Scientist and/or Scientist