Principal Scientist, Early DCT Lead

Job description

Job Description Position Overview Large Molecule Drug Substance Development is seeking an accomplished scientific leader to direct the strategy and execution of biologics drug substance programs at our Rahway, New Jersey site. This highly visible position combines cross-functional CMC program leadership with deep 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 (FIH) milestones while establishing robust, phase-appropriate processes that enable late-stage development and commercialization. The role is accountable for the drug substance manufacturing process development and in-process control strategies, transfer process to GMP manufacturing sites, and reliable delivery of clinical drug substance supply. The successful candidate will be an enterprise-minded matrix leader who combines sound scientific judgment with disciplined execution. This individual will align cross-functional teams, anticipate and mitigate program risks, communicate clearly with senior stakeholders, and deliver innovative, scalable, and compliant drug substance solutions. Primary Responsibilities: Integrated CMC Program Leadership (DCT Lead): Program Accountability: Lead assigned early-stage Development and Commercialization Teams (DCTs), with accountability for integrated CMC strategy, milestone readiness, cross-functional alignment, and advancement through governance decisions. Operating Model Execution: Establish and lead matrixed CMC teams with clear structures, working groups, decision rights, timelines, escalation paths, and functional accountability. Cross-Functional Alignment: 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. Risk Management and Governance: Identify program risks, evaluate cross-functional trade-offs, develop data-driven contingencies, and provide clear recommendations to senior leaders and governance bodies. Execution Discipline: Maintain delivery rigor through structured meeting cadences, decision logs, action tracking, risk registers, and timely communication across teams and governance forums. Drug Substance Expertise and Strategy: Development and Manufacturing Strategy: Define phase-appropriate drug substance strategies covering cell line development, upstream and downstream process development, scale-up, technology transfer, and clinical supply. Regulatory Strategy and Authoring: 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. Technical Leadership and Problem Solving: Apply expertise across cell line, upstream, and downstream development to solve complex technical and manufacturing issues, integrate multidisciplinary data, and make risk-based recommendations that protect quality, supply, and timelines. People and Organizational Leadership: Talent Development: Coach early-career scientists, functional leads, and technical team members to strengthen scientific depth, cross-functional effectiveness, and execution capabilities. Continuous Improvement and Innovation: Lead initiatives that accelerate FIH timelines, simplify CMC governance and handoffs, strengthen platform approaches, and expand the use of advanced process technologies, modeling, automation, and digital tools. Enterprise Culture: Promote inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and functions. Qualifications and Requirements: Minimum Education and Experience: 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 Integrated CMC and Matrix Leadership: 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. Biologics Drug Substance Development: Proven leadership in cell line, upstream, and downstream process development; scale-up; transfer process to GMP manufacturing sites; clinical manufacturing support; and manufacturing science and technology, with the ability to integrate these disciplines into a cohesive development and control strategy. Regulatory Strategy and Authoring: 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. Risk-Based Decision Making: Proven ability to identify program risks, clarify complex trade-offs, establish contingency plans, and guide decisions using data and scientific judgment. Communication and Influence: Strong collaboration, facilitation, and influencing skills in matrixed environments, with the ability to translate complex technical information into concise, decision-focused communications for governance and executive audiences. Delivery and People Leadership: Demonstrated accountability for milestones and program outcomes, combined with a commitment to mentoring scientists and fostering an inclusive, transparent, high-trust culture. Preferred Experience and Skills 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. Required Skills: 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, Technology Transfer Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakt