Principal Scientist, Early DCT Lead

Merck•Rahway, NJ

4d•$156,900 - $247,000

About The Position

The Principal Scientist, Early DCT Lead is a high-visibility role combining integrated cross-functional program leadership with deep subject-matter expertise in biologics analytical development. As an Early-Stage Development and Commercialization Team (DCT) Lead, the role provides strategic, technical, and operational direction for integrated CMC teams advancing pipeline biologics from candidate selection through early clinical development and First-in-Human milestones, while preparing for commercialization. The role is also an analytical subject-matter expert who guides method development, phase-appropriate integrated analytical control strategies, Critical Quality Attribute assessments, and product characterization. The position is accountable for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression through governance gates. It leads matrixed CMC teams and aligns functions including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, manufacturing, and external partners. The role identifies program risks, develops data-driven contingency plans, and communicates recommendations to senior leaders and governance bodies. Analytical responsibilities include defining control strategies and characterization workflows for early-phase biologics; overseeing CQA, degradation, structure-function, and in-use stability assessments; and guiding analytical contributions to regulatory filings and health-authority responses. The role also troubleshoots complex analytical, formulation, and downstream-processing challenges using advanced characterization expertise. The Principal Scientist mentors scientists and technical project members, champions improvement initiatives to accelerate FIH timelines and streamline CMC governance, and models inclusive leadership, transparent communication, psychological safety, and operational excellence. The role is based primarily in Rahway, New Jersey, with 10% travel. Relocation is available, and visa sponsorship is offered.

Requirements

Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or a related scientific discipline and at least 8 years of relevant biopharmaceutical industry experience; or an M.S. in a related scientific discipline and at least 10 years; or a B.S. in a related scientific discipline and at least 14 years.
Experience serving as a DCT Lead or in an equivalent cross-functional program leadership role, driving execution across drug substance, drug product, analytical, regulatory, quality, device/packaging, manufacturing, and supply-chain functions.
A track record in biologics analytical development, including method design, qualification or validation, method transfer, phase-appropriate specification setting, and elucidation of CQAs and degradation pathways.
Evidence of leadership in analytical sciences and biologics development through active engagement with external consortia, scientific conferences, and/or peer-reviewed publications.
Subject-matter expertise with modern biophysical and biochemical analytical platforms, including separation sciences, mass spectrometry, biophysical techniques, functional/potency assays, and/or process-related residuals.
Direct experience authoring, reviewing, and defending analytical and CMC sections of regulatory filings, health-authority briefing packages, and information requests.
Ability to identify program risks, clarify cross-functional trade-offs, establish contingency pathways, and guide data- and judgment-based decisions.
Exceptional collaboration, facilitation, and influencing skills in matrix environments without direct authority.
Ability to synthesize complex technical data into concise, decision-oriented communications for governance and executive leadership.
Accountability for program delivery and milestone execution, and a commitment to mentoring junior scientists and fostering an inclusive, transparent, high-trust team culture.

Nice To Haves

Experience with accelerated development paradigms, platform strategies, or transition from early-stage development to late-stage commercialization readiness.
Experience with complex biological modalities such as bispecific or multispecific antibodies, antibody-drug conjugates, or fusion proteins.

Responsibilities

Serve as DCT Lead for assigned pipeline biologics, accountable for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progress through governance gates.
Lead and operationalize matrixed CMC teams, establishing team structures, functional working groups, decision rights, timelines, escalation paths, and accountability.
Align Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, manufacturing, and external partner organizations.
Identify program vulnerabilities, assess cross-functional trade-offs, develop data-driven contingency plans, and communicate recommendations to senior leadership and governance bodies.
Maintain structured meeting cadences, decision logs, action tracking, risk registers, and timely communication across teams and governance groups.
Define phase-appropriate analytical control strategies, product characterization workflows, and specification-setting rationales for early-phase biological modalities.
Oversee evaluation of CQAs, forced degradation pathways, structure-function relationships, and in-use stability and compatibility studies.
Guide or contribute to authoring, review, and approval of analytical sections of IND/IMPD filings, briefing books, and responses to health-authority queries; lead or participate in Analytical Technical Reviews.
Troubleshoot complex analytical and formulation or downstream-processing challenges using advanced characterization knowledge.
Mentor and coach early-career scientists, functional leads, and technical project members.
Champion initiatives to accelerate FIH cycle times, streamline CMC governance handoffs, and adopt innovative analytical or digital/informatics workflows.
Model inclusive leadership, psychological safety, transparent communication, and operational excellence.