Principal Scientist, Early DCT Lead

MSD•Rahway, NJ

4d•$156,900 - $247,000

About The Position

The Principal Scientist, Early DCT Lead, combines integrated cross-functional program leadership with subject-matter expertise in biologics analytical development. The role provides strategic, technical, and operational direction for integrated CMC teams advancing pipeline biologics from candidate selection through early clinical development and First-in-Human milestones, while establishing groundwork for commercialization. As an analytical subject-matter expert, the role guides focused method development, phase-appropriate analytical control strategies, Critical Quality Attribute assessments, and robust characterization to support high-quality pipeline progression. The role leads assigned Early-Stage Development and Commercialization Teams (DCTs), with accountability for integrated CMC strategy, milestone readiness, cross-functional alignment, and progression through governance gates. It also provides analytical strategy and technical guidance, contributes to regulatory filings and health-authority responses, solves complex technical challenges, mentors scientists and project members, and champions continuous improvement and inclusive leadership.

Requirements

Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or a related scientific discipline and at least 8 years of relevant biopharmaceutical industry experience; or an M.S. in a related discipline and at least 10 years; or a B.S. in a related discipline and at least 14 years.
Demonstrated experience as a DCT lead or in an equivalent cross-functional program leadership role, driving execution across drug substance, drug product, analytical, regulatory, quality, device/packaging, manufacturing, and supply chain functions.
Proven biologics analytical development experience, including method design, qualification/validation, method transfer, phase-appropriate specification setting, and elucidation of CQAs and degradation pathways.
Demonstrated analytical-science and biologics-development leadership through active engagement with external consortia, scientific conferences, and/or peer-reviewed publications.
Subject-matter expertise with modern biophysical and biochemical analytical platforms, including separation sciences such as U/HPLC, SEC, IEX, HIC, RP, CE-SDS, and cIEF; mass spectrometry; biophysical techniques; functional/potency assays; and/or process-related residuals.
Direct experience authoring, reviewing, and defending analytical and CMC sections of regulatory filings such as IND or IMPD, health-authority briefing packages, and information requests.
Ability to identify program risks, clarify cross-functional trade-offs, establish contingency pathways, and guide decisions using data and judgment.
Exceptional collaboration, facilitation, and influencing skills in matrix environments without direct authority.
Ability to synthesize complex technical data into concise, decision-oriented communications for governance and executive leadership.
Demonstrated accountability for program delivery and milestone execution.
Commitment to mentoring junior scientists and fostering an inclusive, transparent, high-trust team culture.

Nice To Haves

Experience with accelerated development paradigms, platform strategies, or transition from early-stage to late-stage commercialization readiness.
Experience with complex biological modalities such as bispecific or multispecific antibodies, antibody-drug conjugates, or fusion proteins.

Responsibilities

Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, accountable for integrated CMC strategy, milestone readiness, cross-functional alignment, and progression through governance gates.
Lead and operationalize matrixed CMC project teams by establishing team structures, working groups, decision rights, timelines, escalation pathways, and accountability.
Align CMC functions and external partners, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and partner organizations.
Identify program vulnerabilities, assess cross-functional trade-offs, develop data-driven contingency plans, and communicate recommendations to leadership, governance bodies, and stakeholders.
Maintain project execution rigor through meeting cadences, decision logs, action tracking, risk registers, and timely communication.
Define phase-appropriate analytical control strategies, characterization workflows, and specification-setting rationales for early-phase biologics.
Oversee assessment of Critical Quality Attributes, degradation pathways, structure-function relationships, and in-use stability and compatibility to establish phase-appropriate comparability and shelf-life.
Guide and contribute to analytical sections of global regulatory filings, briefing books, and responses to health-authority queries; lead or participate in Analytical Technical Reviews.
Apply advanced characterization expertise to troubleshoot analytical, formulation, and downstream processing challenges.
Mentor and coach early-career scientists, functional leads, and technical project members.
Champion initiatives to accelerate First-in-Human cycle times, streamline CMC governance handoffs, and adopt innovative analytical or digital/informatics workflows.
Model inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and departments.