Principal Scientist, Early DCT Lead

Merck • Rahway, NJ

5d • $173,200 - $272,600 • Onsite

About The Position

Large Molecule Drug Substance Development seeks a scientific leader to direct the strategy and execution of biologics drug substance programs at the Rahway, New Jersey site. The role combines cross-functional CMC program leadership with expertise in cell line, upstream, and downstream process development; scale-up; technology transfer; and clinical manufacturing. The leader advances assigned biologics from candidate selection through early clinical development and First-in-Human milestones, establishing phase-appropriate processes that support later development and commercialization. The position is accountable for drug substance process development and in-process control strategies, transfer of processes to GMP manufacturing sites, and reliable clinical drug substance supply.

The successful candidate will lead matrixed teams, align cross-functional contributors, anticipate and mitigate program risks, communicate with senior stakeholders, and deliver scalable, compliant drug substance solutions. The role also includes regulatory strategy and authoring, technical problem solving, mentoring, and continuous improvement across CMC development and governance.

Requirements

• 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 an M.S. in a related discipline with at least 10 years; or a B.S. in a related discipline with at least 14 years.
• 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.
• Proven leadership in cell line, upstream, and downstream process development; scale-up; transfer of processes to GMP manufacturing sites; clinical manufacturing support; and manufacturing science and technology.
• 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.
• Ability to identify program risks, clarify complex trade-offs, establish contingency plans, and guide decisions using data and scientific judgment.
• Strong collaboration, facilitation, and influencing skills in matrixed environments, including the ability to translate complex technical information into concise, decision-focused communications for governance and executive audiences.
• Demonstrated accountability for milestones and program outcomes, and commitment to mentoring scientists and fostering an inclusive, transparent, high-trust culture.
• Skills listed include biologics, biopharmaceuticals, cell culture process development, cell line development, combination products, data analysis, drug formulations, finite element analysis (FEA), matrix leadership, pharmaceutical industry, pharmaceutical process development, pharmaceutical research, pharmaceutical sciences, pharmaceutics, professional collaboration, Quality by Design, regulatory filings, regulatory operations, regulatory processes, risk avoidance, strategy development, and technology transfer.

Nice To Haves

• Experience using accelerated development, platform, or prior-knowledge approaches to shorten timelines while maintaining 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.

Responsibilities

• Lead assigned early-stage Development and Commercialization Teams (DCTs), accountable for integrated CMC strategy, milestone readiness, cross-functional alignment, and advancement through governance decisions.
• Establish and lead matrixed CMC teams with clear structures, working groups, decision rights, timelines, escalation paths, and functional accountability.
• 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.
• Identify program risks, evaluate cross-functional trade-offs, develop data-driven contingencies, and provide recommendations to senior leaders and governance bodies.
• Maintain execution discipline using meeting cadences, decision logs, action tracking, risk registers, and timely communication.
• Define phase-appropriate drug substance strategies covering cell line development, upstream and downstream process development, scale-up, technology transfer, and clinical supply.
• Lead or support 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.
• Apply expertise across cell line, upstream, and downstream development to solve technical and manufacturing issues, integrate multidisciplinary data, and make risk-based recommendations that protect quality, supply, and timelines.
• Coach early-career scientists, functional leads, and technical team members.
• Lead initiatives to accelerate FIH timelines, simplify CMC governance and handoffs, strengthen platform approaches, and expand use of advanced process technologies, modeling, automation, and digital tools.
• Promote inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and functions.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.
• Relocation assistance is indicated as domestic/international relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree