Principal Scientist, Early DCT Lead

MSD • Rahway, NJ

4d • $173,200 - $272,600

About The Position

Large Molecule Drug Substance Development is seeking an accomplished 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 will advance assigned biologics from candidate selection through early clinical development and First-in-Human milestones while establishing robust, phase-appropriate processes that enable late-stage development and commercialization. The role is accountable for drug substance manufacturing process development and in-process control strategies, transfer of processes to GMP manufacturing sites, and reliable delivery of clinical drug substance supply.

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

The position leads assigned early-stage Development and Commercialization Teams (DCTs), with accountability for integrated CMC strategy, milestone readiness, cross-functional alignment, and advancement through governance decisions. It defines phase-appropriate drug substance strategies and leads or supports drug substance content for global regulatory submissions. The role also coaches scientists and functional leads, and leads improvements that accelerate FIH timelines, strengthen platform approaches, and expand use of advanced process technologies, modeling, automation, and digital tools.

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.
• 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; process transfer 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, with a commitment to mentoring scientists and fostering an inclusive, transparent, high-trust culture.
• Required skills 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 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.

Responsibilities

• Lead assigned early-stage Development and Commercialization Teams, with accountability 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 through 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 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.
• 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 families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.
• Domestic or international relocation.

What This Job Offers

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