CMC Biologics Analytical Lead – Principal Scientist

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MISSION

The CMC Biologics Analytical Lead - Principal Scientist is responsible for coordinating and leading the analytical strategy, planning, and oversight across the drug development lifecycle, from early-stage development through late-stage development and commercialization readiness. This role ensures that analytical activities are scientifically sound, aligned with CMC development objectives, and executed in accordance with applicable regulatory requirements and quality standards.

Working in close collaboration with the internal analytical team and key cross-functional and external partners, the CMC Analytical Lead provides scientific leadership, establishes analytical priorities, and drives alignment across stakeholders to ensure the timely delivery of fit-for-purpose analytical methods, robust data packages, and comprehensive analytical control strategies.

Key Responsibilities

1. Analytical Strategy and Leadership

• Define and lead the bioanalytical strategy in alignment with the overall CMC development strategy and product lifecycle objectives.
• Establish analytical priorities, development plans, and key milestones from early-stage development through late-stage clinical development and commercialization readiness.
• Ensure appropriate progression of analytical methods, considering product knowledge, process development, formulation, stability, and evolving regulatory expectations.
• Provide scientific and technical leadership to ensure analytical strategies are risk-based, phase-appropriate, and fit for purpose.

2. Cross-Functional Coordination and Collaboration

• Work in close collaboration with the internal analytical team to define analytical strategy, align priorities, resolve technical challenges, and ensure consistent execution of analytical activities.
• Coordinate activities and maintain strong partnerships with internal stakeholders, including CMC, process development, formulation, quality control, quality assurance, regulatory affairs, and manufacturing.
• Serve as the central point of coordination for bioanalytical strategy and oversight across relevant internal and external partners.
• Facilitate effective communication, decision-making, and alignment across stakeholders to support program timelines and development objectives.

3. External Partner and Vendor Oversight

• Provide scientific and strategic oversight of external analytical laboratories, contract development and manufacturing organizations (CDMOs), and other relevant service providers.
• Define expectations, deliverables, timelines, and responsibilities for outsourced analytical activities.
• Review and critically assess analytical development plans, method qualification and validation strategies, technical reports, and data packages.
• Monitor partner performance, identify risks and dependencies, and proactively drive resolution of technical or operational issues.

4. Analytical Method Development and Lifecycle Management

• Oversee the development, qualification, validation, transfer, and lifecycle management of analytical methods, as appropriate to the development stage and intended use.
• Ensure analytical methods are suitable for their intended purpose and support characterization, release testing, stability studies, comparability assessments, and other CMC requirements.
• Guide the development of scientifically justified analytical control strategies and specifications in collaboration with relevant technical and quality functions.
• Promote consistency, robustness, and appropriate lifecycle management of analytical methods across development stages and testing sites.

5. Regulatory Readiness and Technical Documentation

• Ensure analytical strategies and deliverables align with applicable regulatory guidance, compendial requirements, and relevant quality standards.
• Contributes to the preparation and review of analytical sections of CMC regulatory submissions, including supporting documentation for clinical and marketing applications.
• Support regulatory interactions, inspections, and responses to agency questions related to analytical development and control strategies.
• Ensure analytical data and documentation are scientifically justified, traceable, and suitable for regulatory review.

6. Risk Management and Continuous Improvement

• Identify and proactively manage analytical risks that could affect product quality, development timelines, or regulatory readiness.
• Drive resolution of complex analytical challenges through structured scientific assessment, cross-functional collaboration, and evidence-based decision-making.
• Establish effective oversight mechanisms to monitor progress, deliverables, and analytical readiness across programs.
• Promote continuous improvement, knowledge sharing, and the application of scientific and technological advances to analytical development.

Key Interfaces

• CMC and product development leadership
• Internal analytical development and characterization teams
• Process development and formulation development
• Quality control and quality assurance
• Regulatory affairs and CMC regulatory strategy
• Manufacturing and technology transfer teams
• External analytical laboratories, CDMOs, and specialist service providers

Required Qualifications and Experience

• Advanced degree (PhD preferred, or equivalent experience) in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related.
• Strong experience in analytical development, bioanalytical sciences, or CMC analytical functions within the biopharmaceutical or pharmaceutical industry.
• Coordination of analytical activities and provision of scientific oversight across multiple development stages.
• Strong understanding of analytical method development, qualification, validation, transfer, and lifecycle management.
• Experience managing external partners and working effectively within complex, cross-functional development environments.
• Knowledge of relevant regulatory expectations and quality requirements for analytical development and CMC documentation.
• Proven ability to lead technical discussions, align stakeholders, manage competing priorities, and drive deliverables to completion.

Key Competencies

• Strategic and scientific leadership
• Strong analytical and critical-thinking skills
• Cross-functional coordination and stakeholder management
• External partner oversight and relationship management
• Clear communication and effective decision-making
• Risk assessment and problem-solving
• Planning, prioritization, and delivery against milestones
• Collaborative leadership and continuous improvement