Principal Scientist, Early DCT Lead

Job description

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: 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. Preferred Experience and Skills: 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). Required Skills: Analytical Method Development, Analytical Method Development, Analytical Thinking, Assay Development, Bioanalytical Analysis, Biopharmaceuticals, Biotechnology, Chromatographic Techniques, Clinical Judgment, Commercialization, Cross-Functional Project Management, Cross-Functional Teamwork, Dosage Forms, Early Phase Clinical Trials, Ethical Compliance, Executive Leadership, Inclusive Leadership, Influencing Skills, Liquid Chromatography (LC), Matrix Leadership, Matrix Management, Mentoring Staff, Meth