Principal Scientist, Early DCT Lead

MSD • Rahway, NJ

3d • 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 development teams establish robust formulation, packaging/device, process, and manufacturing strategies through scientific understanding and characterization, using experimental design, analytical tools, and predictive approaches to support product and process selection. The group enables translation of preclinical candidates into non-oral drug products.

The Principal Scientist will serve as an Early-Stage Development and Commercialization Team (DCT) Leader for assigned pipeline biologics. The role provides strategic, technical, and operational direction to integrated CMC teams, progressing programs from candidate selection through early clinical development and First-in-Human milestones while laying groundwork for commercialization. The successful candidate brings biologics product development experience, supports relevant drug product activities, understands end-to-end CMC disciplines, and leads matrixed teams with a focus on robustness at launch.

The DCT Leader is accountable for integrated CMC strategy, milestone readiness, cross-functional alignment, and progress through formal governance gates. The role also provides drug product leadership for early-stage work such as composition selection, scalable process development, packaging/device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support. The position includes mentoring team members, supporting organizational strategy and innovation, and demonstrating inclusive leadership, sound judgment, adaptability, and strong communication skills.

Requirements

• Ph.D. in a related discipline and at least 8 years of relevant biopharmaceutical industry experience; or M.S. and at least 10 years; or B.S. and at least 14 years.
• Experience as a Development and Commercialization Team lead or equivalent integrated program leader, with demonstrated ability to lead cross-functional development or commercialization teams and align functions, divisions, and partner organizations.
• 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 in a matrixed environment without direct authority.
• Ability to translate complex cross-functional information into clear, decision-oriented communications for 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 monoclonal antibodies, 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.

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.
• External publications or patents reflecting relevant biologics product development, regulatory filing, drug delivery, formulation, or process development experience.

Responsibilities

• Lead assigned pipeline biologics as the Early-Stage Development and Commercialization Team (DCT) Leader, with 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 clear accountability.
• Align activities across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and external partners.
• Frame program decisions, clarify cross-functional trade-offs, identify and mitigate risks, and escalate issues to appropriate stakeholders.
• Maintain project rigor through meeting cadences, decision logs, action tracking, risk registers, and timely communications across teams and governance bodies.
• Provide drug product leadership and support for composition selection, scalable process development, packaging/device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support.
• Mentor and guide scientists or team members, as appropriate, to complete milestones and laboratory or regulatory documentation.
• Contribute to organizational strategic and innovation objectives.

Benefits

• Annual bonus and long-term incentive, if applicable.
• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Relocation assistance is available domestically or internationally.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal