Principal Scientist, Early DCT Lead

Job Description

The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms, including injections, implants, inhaled and ocular products, for small, intermediate and large molecules from preclinical toxicology studies through commercialization. Our development teams ensure robust formulation, primary packaging/device, process and manufacturing strategies through deep scientific understanding and characterization, enabling scalable development plans without compromising stability, safety, efficacy or delivery. During development, we leverage smart experimental design, cutting-edge analytical tools and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

Our team is seeking an accomplished, highly collaborative scientific and matrix leader for a Principal Scientist (R5) – Development and Commercialization Team (DCT) Leader position at our research facility in Rahway, New Jersey. As an Early-Stage DCT Leader, you will provide strategic, technical, and operational direction for integrated CMC teams, advancing a portfolio of pipeline biologics from candidate selection through early clinical development and First-in-Human (FIH) milestones, while laying the groundwork for commercialization. The candidate is expected to have biologics product development experience and will continue to support relevant drug product activities, combined with broad working-knowledge of end-to-end CMC disciples and a proven ability to lead matrixed teams with an enterprise, “robustness at launch” mindset. The ideal candidate bridges enterprise matrix leadership with rigorous technical acumen, demonstrating a proven track record of driving cross-functional alignment, managing program risk, and championing scientific excellence.

Primary Responsibilities

Integrated CMC Program Leadership (DCT Lead):

• •Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, cross-functional alignment, and progression across formal governance gates (e.g., Development & Commercialization Review Committee [DCRC] milestones).
• •Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, milestone-driven timelines, escalation pathways, and single-point accountability across functions.

Drive strategic and operational alignment across key CMC interfaces, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and external partner organizations.

Frame key program decisions, clarify cross-functional trade-offs, identify and mitigate risks, and ensure timely escalation to functional leadership, governance, regulatory, quality, manufacturing, supply, or commercial stakeholders when needed.

Drive project rigor through structured meeting cadences, decision logs, action tracking, transparent risk registers, and timely cross-functional communication across working groups and governance bodies.

Drug Product Technical and strategic Leadership:

Provide drug product leadership and support for relevant early-stage activities, including composition selection, scalable process development, primary packaging/device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support.

Mentor and guide scientists or team members, as appropriate, to support completion of key milestones and required laboratory or regulatory documentation.

Contribute to ideating, leading, and championing organizational strategic and innovation objectives aligned with broader organizational goals.

Demonstrate accountability, adaptability, sound judgment, inclusive leadership behaviors, and strong communication and interpersonal skills.

Minimum Education 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
• •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:

Experience serving 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 drive alignment across functions, divisions, and partner organizations.

Strong understanding of integrated CMC development and key interfaces across drug substance, drug product, analytical, regulatory, quality, packaging/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 activities.

Strong collaboration, influencing, facilitation, and communication skills, with 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.

Proven 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 mAbs, ADCs, fusion proteins, 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.

Preferred experience leading or significantly contributing to CMC teams through late-stage development, regulatory filing, approval, technology transfer, validation readiness, or launch activities.

Required Skills:

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, Technology Transfer

Preferred Skills:

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