Principal Scientist, Early DCT Lead

Job Description

Role Description:

This high-visibility role combines integrated cross-functional program leadership with deep subject-matter expertise (SME) in biologics analytical development. As an Early-Stage DCT Leader, you will provide strategic, technical, and operational direction for integrated CMC teams, advancing a portfolio of pipeline biologics from candidate selection through early clinical development and First-in-Human (FIH) milestones, while laying the groundwork for commercialization. Simultaneously, you will serve as an analytical SME within the department, responsible for guiding focused method development, driving phase-appropriate integrated analytical control strategies, assessing Critical Quality Attributes (CQAs) for each molecule, and championing robust characterization to enable swift, high-quality pipeline progression.

The ideal candidate bridges enterprise matrix leadership with rigorous technical acumen, demonstrating a proven track record of driving cross-functional alignment, managing program risk, and championing scientific excellence.

Primary Responsibilities:

Integrated CMC Program Leadership (DCT Lead):

• Program Accountability: Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression across formal governance gates (e.g., Development & Commercialization Review Committee [DCRC] milestones).
• Operating Model Execution: Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, milestone-driven timelines, escalation pathways, and single-point accountability across functions.
• Cross-Functional Interface Alignment: Drive strategic and operational alignment across key CMC interfaces, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and external partner organizations.
• Risk Management & Governance: Proactively identify program vulnerabilities, evaluate cross-functional trade-offs, formulate data-driven contingency plans, and communicate recommendations with clarity to senior leadership, governance bodies, and key stakeholders.
• Disciplined Execution & Cadence: Drive project rigor through structured meeting cadences, decision logs, action tracking, transparent risk registers, and timely cross-functional communication across working groups and governance bodies.

Analytical Subject Matter Expertise & Strategy:

• Analytical Control Strategy: Define and champion phase-appropriate analytical control strategies, product characterization workflows, and specification-setting rationales for early-phase biological modalities (e.g., mAbs, multispecifics, fusion proteins, novel biotherapeutics).
• CQA & Degradation Profiling: Oversee the evaluation of Critical Quality Attributes (CQAs), forced degradation pathways, structure-function relationships, and in-use stability/compatibility studies to establish clinical phase-appropriate comparability and shelf-life.
• Regulatory Authoring & Technical Reviews: Guide and contribute to the technical authoring, review, and approval of analytical sections of global regulatory filings (IND/IMPD), briefing books, and responses to health authority queries. Lead or actively participate in Analytical Technical Reviews (ATRs).
• Technical Problem Solving: Leverage advanced knowledge of physicochemical, biophysical, and functional characterization techniques to troubleshoot complex analytical and formulation/downstream processing challenges.

People, Mentorship & Organizational Leadership:

• Talent Development: Mentor and coach early-career scientists, functional leads, and technical project members, cultivating cross-functional acumen, scientific depth, and project execution capabilities.
• Continuous Improvement: Champion departmental and cross-functional initiatives aimed at accelerating FIH cycle times, streamlining CMC governance handoffs, and adopting innovative analytical or digital/informatics workflows.
• Enterprise Culture: Model inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and departmental functions.

Qualifications & Requirements:

Minimum Education Requirements:

• Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or a related scientific discipline with a minimum of 8 years of relevant biopharmaceutical industry experience; OR
• M.S. in a related scientific discipline with a minimum of 10 years of relevant biopharmaceutical industry experience; OR
• B.S. in a related scientific discipline with a minimum of 14 years of relevant biopharmaceutical industry experience.

Required Experience and Skills:

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