Principal Scientist, Clinical Process Development

Responsibilities 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 (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. Qualifications BS/BA in Chemistry, Biochemistry, Chemical Engineering, or related field and 6+ years of pharmaceutical industry experience in a chemistry, analytical, or characterization laboratory setting. OR MS/MA in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience. OR PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 2+ years of similar experience; may include postdoc experience. 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 product development, including process design, optimization, scale‑up, validation, and lifecycle management. Strong cross‑functional understanding of drug 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 intelligence, and emerging technologies for application to internal development programs. Maintains broad knowledge of scientific principles and theories, with intellectual mastery and recognized expertise in one or more scientific disciplines. Understands related functional areas and interdependencies across drug development, manufacturing, and regulatory domains. Demonstrates advanced knowledge and judgment in selecting, recommending, and implementing laboratory and manufacturing equipment and technologies. Proven ability to lead multiple teams and influence cross‑functional and matrixed organizations; provides technical leadership to junior scientists and indirect teams. Exhibits strong leadership capability, strategic thinking, and organizational awareness. Excellent computer proficiency and data analysis capability. Exceptional communication, analytical thinking, and complex problem‑solving skills. Sees the broader organizational impact of decisions across programs, departments, and portfolios. Effectively manages multiple high‑priority programs simultaneously with accuracy, efficiency, and accountability. Excellent project management skills, including long‑range planning and execution. Holds self and team accountable for results; sets clear objectives and articulates measurable outcomes. Compensation & Benefits The annual base salary we reasonably expect to pay is $130,800.00–$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity‑based long‑term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Equal Opportunity Employer Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. #J-18808-Ljbffr Neurocrine Biosciences