Principal Scientist, Pharmaceutical Development

Senior Technical Leader, Pharmaceutical Development

Serve 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 develop ability 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 expectations
• Lead 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 organization
• Design, 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 commercialization
• Lead and contribute to process development activities including experimental design (DoE), process modeling, scale-up, validation, and technology transfer to internal and external manufacturing sites
• Serve 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 solutions
• Oversee and collaborate with external partners, including CDMOs and vendors, to ensure appropriate technical capabilities, quality, compliance, and supply of clinical and commercial materials
• Act as technical lead and company representative during manufacturing campaigns and on-site activities ("person-in-plant"), providing oversight and ensuring successful execution
• Collaborate 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 stages
• Lead 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 members
• Perform other duties as assigned

Requirements:

• 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 setting
• MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above OR
• PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 2+ years of similar experience noted above; may include postdoc experience
• Experience with parenteral drug product development, including monoclonal antibodies, peptides, and conjugates. Experience with combination product design is preferred
• Advanced and comprehensive understanding of cGMP requirements across early- and late-stage drug product manufacturing, with a strong quality and compliance mindset
• Deep technical expertise in parenteral drug product development, including process design, optimization, scale-up, validation, and lifecycle management
• Strong cross-functional understanding of parenteral drug product development from discovery through commercialization, including CMC strategy and regulatory lifecycle considerations
• Expertise managing CROs and CMOs/CDMOs supporting preclinical, clinical, and commercial programs
• Advanced knowledge of analytical methods, method validation, technology transfer, and stability programs
• Extensive knowledge of characterization instrumentation and techniques; evaluates and implements emerging technologies to enhance development capabilities
• Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions
• Experience contributing to strategic planning, budget management, and portfolio-level decision-making
• Experience managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAs
• Assimilates external scientific literature, competitive…