Principal Scientist, Early DCT Lead

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.

• 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 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.

• 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.

• 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.

• Integrated CMC & Matrix Program Leadership: Demonstrated experience serving as a Development and Commercialization Team (DCT) lead or in an equivalent cross-functional program leadership role, driving alignment and execution across drug substance, drug product, analytical, regulatory, quality, device/packaging, manufacturing, and supply chain functions.

• Biologics Analytical Development Depth: Proven track record in biologics analytical development, including method design, qualification/validation, method transfer, phase-appropriate specification setting, and elucidation of Critical Quality Attributes (CQAs) and degradation pathways, as demonstrated by active engagement with external consortia, scientific conferences, and/or peer-reviewed publications showcasing leadership in analytical sciences and biologics development.

• Advanced Characterization Acumen: Subject-matter expertise with modern biophysical and biochemical analytical platforms, including separation sciences (U/HPLC, SEC, IEX, HIC, RP, CE-SDS, cIEF), mass spectrometry (intact mass, peptide mapping, PTMs), biophysical techniques (CD, DSC, DLS, AUC, sub-visible particle analysis), functional/potency assays (ELISA, SPR, cell-based assays), and/or process-related residuals.
• Regulatory Dossier Strategy & Authoring: Direct experience authoring, reviewing, and defending analytical and CMC sections of regulatory filings (IND, IMPD, or equivalent), health authority briefing packages, and information requests.
• Risk Management & Data-Driven Decision-Making: Proven ability to identify program risks, clarify complex cross-functional trade-offs, establish contingency pathways, and guide data- and judgment-based decisions.
• Matrix Communication & Stakeholder Influencing: Exceptional collaboration, facilitation, and influencing skills to navigate matrix environments without direct authority; ability to synthesize complex technical data into concise, decision-oriented communications for governance and executive leadership.
• Delivery & People Leadership: Demonstrated accountability for program delivery and milestone execution, paired with a proven commitment to mentoring junior scientists and fostering an inclusive, transparent, and high-trust team culture.

• Experience with accelerated development paradigms, platform strategies, or transition from early-stage to late-stage commercialization readiness.
• Experience with complex biological modalities (e.g., bispecific/multispecific antibodies, antibody-drug conjugates [ADCs], or fusion proteins).

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The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.