Principal Scientist, Early DCT Lead

Merck•Rahway, NJ

4d•$173,200 - $272,600•Onsite

About The Position

The Sterile Product Development group develops non-oral dosage forms—including injections, implants, inhaled products, and ocular products—for small, intermediate, and large molecules from preclinical toxicology through commercialization. Its work includes formulation, primary packaging and device, process, and manufacturing strategies, supported by scientific characterization, analytical tools, and predictive approaches. The Principal Scientist will serve as an Early-Stage Development and Commercialization Team (DCT) Leader for pipeline biologics at the research facility in Rahway, New Jersey. The role provides strategic, technical, and operational direction for integrated CMC teams as programs advance from candidate selection through early clinical development and First-in-Human milestones, while preparing for commercialization. The position requires biologics product development experience, continued support for relevant drug product activities, broad working knowledge of end-to-end CMC disciplines, and the ability to lead matrixed teams with a focus on robustness at launch. The DCT Leader is accountable for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression through formal governance gates. The role also provides drug product leadership and support for activities such as composition selection, scalable process development, packaging and device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support. The position includes mentoring scientists or team members and contributing to organizational strategy and innovation.

Requirements

Ph.D. in a related discipline and at least 8 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline and at least 10 years; or B.S. in a related discipline and at least 14 years.
Experience as a Development and Commercialization Team lead or in an equivalent integrated program leadership role, leading cross-functional development or commercialization teams.
Strong understanding of integrated CMC development and interfaces across drug substance, drug product, analytical, regulatory, quality, packaging/device, manufacturing, and supply functions.
Ability to identify program risks, clarify cross-functional trade-offs, develop mitigation or contingency plans, and support data- and judgment-based decisions.
Experience supporting development milestones, governance discussions, technical reviews, regulatory submissions, health authority response planning, launch preparedness, or commercialization readiness.
Strong collaboration, influencing, facilitation, and communication skills, including the ability to lead without direct authority and communicate complex information clearly to diverse audiences.
Demonstrated accountability for follow-through, issue resolution, and delivery of program objectives, while fostering an inclusive, transparent, and respectful team culture.
Strong track record in biologics product development, regulatory filing, drug delivery, and complex formulation and process development.
Experience with biologics pipeline programs and modalities such as mAbs, ADCs, fusion proteins, and doublet or triplet co-formulations.
Strong familiarity with biologic analytical methods, drug product specifications, and drug substance downstream formulation considerations.
Demonstrated interest and track record in mentoring junior scientists toward time-bound goals.
Scientific leadership in biologics product development and demonstrated leadership behaviors.
Skills listed include biologics, biopharmaceuticals, biotechnology, cell culture process development, cell line development, CMC development, combination products, cross-functional project management, data analysis, design of experiments, drug delivery, early phase clinical trials, finite element analysis, leadership mentoring, matrix leadership, pharmaceutical process development, pharmaceutical sciences, pharmaceutics, pharmacodynamics, pharmacokinetics, preclinical research, quality by design, regulatory filings, and technology transfer.

Nice To Haves

Experience leading or significantly contributing to CMC teams through late-stage development, regulatory filing, approval, technology transfer, validation readiness, or launch activities.

Responsibilities

Serve as Early-Stage DCT Lead for assigned pipeline biologics and hold accountability for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression through governance gates.
Lead and operationalize matrixed CMC project teams by establishing team structures, functional working groups, decision rights, milestone-driven timelines, escalation pathways, and accountability.
Align work across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant and Commercial Manufacturing, and external partners.
Frame program decisions, clarify cross-functional trade-offs, identify and mitigate risks, and escalate issues to relevant stakeholders when needed.
Use structured meeting cadences, decision logs, action tracking, risk registers, and timely communication to drive project rigor.
Provide drug product leadership and support for composition selection, scalable process development, primary packaging and device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support.
Mentor and guide scientists or team members toward completion of milestones and laboratory or regulatory documentation.
Contribute to organizational strategic and innovation objectives.
Demonstrate accountability, adaptability, sound judgment, inclusive leadership, and strong communication and interpersonal skills.