Principal Scientist, Early DCT Lead

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.

• 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.

• 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.

• 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.

• 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.

• 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.
• Biologics Drug Substance Development: Proven leadership in cell line, upstream, and downstream process development; scale-up; transfer process to GMP manufacturing sites; clinical manufacturing support; and manufacturing science and technology, with the ability to integrate these disciplines into a cohesive development and control strategy.
• Regulatory Strategy and Authoring: Direct experience preparing, reviewing, and defending drug substance and CMC content for INDs, IMPDs, or equivalent filings, as well as briefing packages and responses to health authority requests.
• Risk-Based Decision Making: Proven ability to identify program risks, clarify complex trade-offs, establish contingency plans, and guide decisions using data and scientific judgment.
• Communication and Influence: Strong collaboration, facilitation, and influencing skills in matrixed environments, with the ability to translate complex technical information into concise, decision-focused communications for governance and executive audiences.
• Delivery and People Leadership: Demonstrated accountability for milestones and program outcomes, combined with a commitment to mentoring scientists and fostering an inclusive, transparent, high-trust culture.

• Experience using accelerated development, platform, or prior-knowledge approaches to shorten timelines while maintaining appropriate scientific and regulatory rigor.
• Experience developing complex biologic modalities, including bispecific or multispecific antibodies, antibody-drug conjugates, fusion proteins, or other next-generation protein therapeutics.

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Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.