Principal Scientist, Pharmaceutical Development

Senior Technical Leader, Pharmaceutical DevelopmentServe as a senior technical leader within Pharmaceutical Development, representing CMC project teams across the product lifecycle from early discovery through commercialization and lifecycle management. Provide strategic and scientific leadership in process development, material characterization, and analytical strategies to enable phase-appropriate development, manage developability risks, and support intellectual property and commercial objectives. Establish and oversee CRO/CMO/CDMO partnerships, supporting technical transfer and manufacturing readiness. Represent CMC on cross-functional teams to deliver high-quality drug products that address molecule-specific challenges and meet regulatory and commercial objectives.Your Contributions (include, but are not limited to):Provide scientific and technical leadership across drug product development programs from early discovery through commercial launch, ensuring alignment with program goals, timelines, and regulatory expectationsLead weekly or bi-weekly internal and NBI–CMO/CDMO project team meetings; clearly communicate program progress, risks, resource gaps, and timelines up and down the organizationDesign, develop, and scale robust, phase-appropriate formulations and manufacturing processes using Quality by Design (QbD) principles, statistical analysis, and sound scientific methodologies, with a clear path to commercializationLead and contribute to process development activities including experimental design (DoE), process modeling, scale-up, validation, and technology transfer to internal and external manufacturing sitesServe as a subject matter expert (SME) to investigate and resolve complex technical issues across preformulation, formulation, analytical, and manufacturing activities; drive root cause analysis and implement effective solutionsOversee and collaborate with external partners, including CDMOs and vendors, to ensure appropriate technical capabilities, quality, compliance, and supply of clinical and commercial materialsAct as technical lead and company representative during manufacturing campaigns and on-site activities ("person-in-plant"), providing oversight and ensuring successful executionCollaborate cross-functionally with internal teams (e.g., Discovery, Chemical Development, Analytical, Clinical, Regulatory, Quality, and Supply Chain) to advance programs and ensure effective knowledge transfer across development stagesLead or support CMC strategy and execution, including authorship and review of regulatory submissions (e.g., IND, IMPD, NDA, MAA) and development documentation, ensuring scientific rigor and compliance with global regulatory requirements (ICH, FDA, EMA, cGMP)Drive continuous process verification (CPV) and continuous improvement (CPI) activities through data analysis and monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs)Provide technical guidance, mentorship, and leadership to team membersPerform other duties as assignedRequirements:BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 6+ years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory settingMS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above ORPhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 2+ years of similar experience noted above; may include postdoc experienceExperience with parenteral drug product development, including monoclonal antibodies, peptides, and conjugates. Experience with combination product design is preferredAdvanced and comprehensive understanding of cGMP requirements across early- and late-stage drug product manufacturing, with a strong quality and compliance mindsetDeep technical expertise in parenteral drug product development, including process design, optimization, scale-up, validation, and lifecycle managementStrong cross-functional understanding of parenteral drug product development from discovery through commercialization, including CMC strategy and regulatory lifecycle considerationsExpertise managing CROs and CMOs/CDMOs supporting preclinical, clinical, and commercial programsAdvanced knowledge of analytical methods, method validation, technology transfer, and stability programsExtensive knowledge of characterization instrumentation and techniques; evaluates and implements emerging technologies to enhance development capabilitiesDemonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissionsExperience contributing to strategic planning, budget management, and portfolio-level decision-makingExperience managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAsAssimilates external scientific literature, competitive intelligence, and emerging technologies for application to internal development programsMaintains broad knowledge of scientific principles and theories, with intellectual mastery and recognized expertise in one or more scientific disciplinesUnderstands related functional areas and interdependencies across parenteral drug product development, manufacturing, and regulatory domainsDemonstrates advanced knowledge and judgment in selecting, recommending, and implementing laboratory and manufacturing equipment and technologiesProven ability to lead multiple teams and influence cross-functional and matrixed organizations; provides technical leadership to junior scientists and indirect teamsExhibits strong leadership capability, strategic thinking, and organizational awarenessExcellent computer proficiency and data analysis capabilityExceptional communication, analytical thinking, and complex problem-solving skillsSees the broader organizational impact of decisions across programs, departments, and portfoliosEffectively manages multiple high-priority programs simultaneously with accuracy, efficiency, and accountabilityExcellent project management skills, including long-range planning and executionHolds self and team accountable for results; sets clear objectives and articulates measurable outcomes