Principal Scientist, Early DCT Lead

Job Description

Position Overview

Large Molecule Drug Substance Development is seeking an accomplished scientific leader to direct the strategy and execution of biologics drug substance programs at our Rahway, New Jersey site.

This highly visible position combines cross-functional CMC program leadership with deep expertise in cell line, upstream, and downstream process development; scale-up; technology transfer; and clinical manufacturing. The leader will advance assigned biologics from candidate selection through early clinical development and First-in-Human (FIH) milestones while establishing robust, phase-appropriate processes that enable late-stage development and commercialization. The role is accountable for the drug substance manufacturing process development and in-process control strategies, transfer process to GMP manufacturing sites, and reliable delivery of clinical drug substance supply.

The successful candidate will be an enterprise-minded matrix leader who combines sound scientific judgment with disciplined execution. This individual will align cross-functional teams, anticipate and mitigate program risks, communicate clearly with senior stakeholders, and deliver innovative, scalable, and compliant drug substance solutions.

Primary Responsibilities:

Integrated CMC Program Leadership (DCT Lead):

• Program Accountability: Lead assigned early-stage Development and Commercialization Teams (DCTs), with accountability for integrated CMC strategy, milestone readiness, cross-functional alignment, and advancement through governance decisions.
• Operating Model Execution: Establish and lead matrixed CMC teams with clear structures, working groups, decision rights, timelines, escalation paths, and functional accountability.
• Cross-Functional Alignment: Coordinate strategy and execution across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, pilot and commercial manufacturing, and external partners.
• Risk Management and Governance: Identify program risks, evaluate cross-functional trade-offs, develop data-driven contingencies, and provide clear recommendations to senior leaders and governance bodies.
• Execution Discipline: Maintain delivery rigor through structured meeting cadences, decision logs, action tracking, risk registers, and timely communication across teams and governance forums.

Drug Substance Expertise and Strategy:

• Development and Manufacturing Strategy: Define phase-appropriate drug substance strategies covering cell line development, upstream and downstream process development, scale-up, technology transfer, and clinical supply.
• Regulatory Strategy and Authoring: Lead or support the strategy, preparation, review, and approval of drug substance content for global submissions, including INDs, IMPDs, briefing packages, and health authority responses. Lead or participate in drug substance technical reviews.
• Technical Leadership and Problem Solving: Apply expertise across cell line, upstream, and downstream development to solve complex technical and manufacturing issues, integrate multidisciplinary data, and make risk-based recommendations that protect quality, supply, and timelines.

People and Organizational Leadership:

• Talent Development: Coach early-career scientists, functional leads, and technical team members to strengthen scientific depth, cross-functional effectiveness, and execution capabilities.
• Continuous Improvement and Innovation: Lead initiatives that accelerate FIH timelines, simplify CMC governance and handoffs, strengthen platform approaches, and expand the use of advanced process technologies, modeling, automation, and digital tools.
• Enterprise Culture: Promote inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and functions.

Qualifications and Requirements:

Minimum Education and Experience:

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, or a related discipline, with at least 8 years of relevant biopharmaceutical industry experience; or
• M.S. in a related discipline, with at least 10 years of relevant biopharmaceutical industry experience; or
• B.S. in a related discipline, with at least 14 years of relevant biopharmaceutical industry experience.

Required Experience and Skills

• Integrated CMC and Matrix Leadership: Demonstrated success leading cross-functional CMC teams or complex biologics programs and aligning execution across drug substance, drug product, analytical development, regulatory, quality, manufacturing, and supply chain functions.

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