Principal Scientist, Early DCT Lead

MSD•Rahway, NJ

4d•$173,200 - $272,600•Onsite

About The Position

The Sterile Product Development (SPD) 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. The group develops formulation, primary packaging and device, process, and manufacturing strategies using scientific understanding and characterization, experimental design, analytical tools, and predictive approaches to support scalable development while maintaining stability, safety, efficacy, and delivery. 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, advancing programs from candidate selection through early clinical development and First-in-Human milestones while preparing for commercialization. The position requires biologics product development experience, continued support of relevant drug product activities, broad working knowledge of end-to-end CMC disciplines, and the ability to lead matrixed teams with a focus on robustness at launch. The role is based at the research facility in Rahway, New Jersey. The position is regular status, offers domestic or international relocation, visa sponsorship, and requires 10% travel. The employee is eligible for an annual bonus and long-term incentive, if applicable. The stated salary range for the primary location is $173,200 to $272,600.

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.
Experience as a Development and Commercialization Team lead or in an equivalent integrated program leadership role, with demonstrated ability to lead cross-functional development or commercialization teams and align functions, divisions, and partners.
Strong understanding of integrated CMC development and interfaces across drug substance, drug product, analytical, regulatory, quality, packaging and device, manufacturing, and supply functions.
Ability to identify program risks, clarify cross-functional trade-offs, develop practical mitigation or contingency plans, and support data- and judgment-based decision-making.
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 effectively 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, reflected through industry experience and, where applicable, external publications or patents.
Experience with biologics pipeline programs and modalities such as monoclonal antibodies, antibody-drug conjugates, 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.
Required skills listed: Biologics, Biopharmaceuticals, Biotechnology, Cell Culture Process Development, Cell Line Development, CMC Development, Combination Products, Cross-Functional Project Management, Data Analysis, Design of Experiments (DOE), Drug Delivery, Early Phase Clinical Trials, Finite Element Analysis (FEA), Leadership Mentoring, Matrix Leadership, Next Generation Science Standards, Pharmaceutical Process Development, Pharmaceutical Sciences, Pharmaceutics, Pharmacodynamics, Pharmacokinetics, Preclinical Research, Quality by Design, Regulatory Filings, and Technology Transfer.

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.

Responsibilities

Serve as Early-Stage DCT Lead for assigned pipeline biologics, accountable for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression through formal governance milestones.
Lead and operationalize matrixed CMC project teams by establishing team structures, functional working groups, decision rights, milestone-driven timelines, escalation pathways, and clear accountability.
Drive alignment across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant and Commercial Manufacturing, and external partners.
Frame program decisions, clarify cross-functional trade-offs, identify and mitigate risks, and escalate issues to appropriate functional, governance, regulatory, quality, manufacturing, supply, or commercial stakeholders.
Maintain project rigor through structured meeting cadences, decision logs, action tracking, risk registers, and timely cross-functional communication.
Provide drug product leadership and support for early-stage activities, including composition selection, scalable process development, primary packaging and device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support.
Mentor and guide scientists or team members, as appropriate, to support key milestones and completion of laboratory or regulatory documentation.
Contribute to developing, leading, and championing organizational strategic and innovation objectives aligned with broader organizational goals.
Demonstrate accountability, adaptability, sound judgment, inclusive leadership, and strong communication and interpersonal skills.