Scientific Director, Pharmaceutical Development Analytics

The International Society for Pharmaceutical Engineering, Inc.; Northern, San Diego (KY, CA); Hybrid; USD 163,000 - 223,000; Full time

Benefits offered by this job

retirement savings plan (with company.

paid vacation

holiday and personal days

paid caregiver/parental and medical le

health benefits

Job summary

Neurocrine Biosciences seeks a Scientific Director, Pharmaceutical Development Analytics, a senior technical contributor driving data-driven drug product development across the CMC lifecycle.

You will partner across MSAT, Quality, Regulatory CMC, Commercial Manufacturing, and Supply Chain to transform complex data into actionable insights that improve product performance and regulatory defensibility.

Qualifications

• Bachelor's degree in Chemical Engineering with 12+ years of pharmaceutical industry experience.
• Master's degree in Chemical Engineering with 10+ years of relevant experience.
• PhD in Chemical Engineering with 8+ years of relevant experience.
• Extensive managerial experience is required.
• Demonstrated expertise in DoE, multivariate analysis, process characterization, statistical modeling and data visualization.
• Working knowledge of solid oral dosage formulation and manufacturing processes.
• Experience supporting late-stage development and global regulatory submissions.
• Proficiency with JMP, R, Python or comparable software.
• Excellent collaboration, communication, and technical influencing skills.

Responsibilities

• Serve as the portfolio-level statistical and quantitative sciences expert supporting drug product development.
• Provide technical leadership across multiple CMC programs to strengthen understanding and decision making.
• Mentor scientists and promote best practices in statistical thinking and experimental design.
• Design and apply advanced statistical methods including DoE, multivariate analysis, and response surface modeling.
• Integrate development, analytical, and manufacturing data to identify CMAs, CPPs, and design space.
• Translate complex datasets into scientifically sound recommendations to improve formulation and product quality.
• Support regulatory submissions and lifecycle management activities.

Skills

DoE

Multivariate analysis

Process characterization

Statistical modeling

Data visualization

JMP

R

Python

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical Engineering

PhD in Chemical Engineering

Tools

JMP

R

Python

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

The Scientific Director, Pharmaceutical Development Analytics is a senior technical individual contributor and portfolio-level quantitative expert responsible for advancing data-driven drug product development across the CMC lifecycle. Embedded within Manufacturing, Science & Technology (MSAT), this role applies advanced statistics, experimental design, quantitative modeling, and mechanistic understanding to strengthen formulation and process development, process characterization, control strategies, and regulatory submissions.

The Scientific Director partners across Technical Operations, Quality, Regulatory CMC, Commercial Manufacturing, and Supply Chain to transform complex development and manufacturing data into actionable scientific insights that improve product performance, process robustness, and regulatory defensibility.

Your Contributions (include, but are not limited to):

• Serve as the portfolio-level statistical and quantitative sciences expert supporting drug product development from post-Proof of Concept through commercialization

• Provide technical leadership across multiple CMC programs to strengthen process understanding, lifecycle knowledge management, and data-driven decision making

• Mentor scientists and promote best practices in statistical thinking, experimental design, and quantitative analysis

Development Analytics & Modeling

• Design and apply advanced statistical methods, including Design of Experiments (DoE), multivariate analysis, response surface modeling, and process variability analysis

• Integrate development, analytical, and manufacturing data to identify critical material attributes (CMAs), critical process parameters (CPPs), process sensitivities, and design space

• Translate complex datasets into scientifically sound recommendations that improve formulation performance, manufacturability, and product quality

Formulation & Process Development

• Partner with Pharmaceutical Development scientists to optimize formulations and manufacturing processes using data-driven and mechanistic approaches

• Support process characterization, scale-up, robustness assessments, risk analyses, troubleshooting, and root-cause investigations

• Guide development of robust control strategies by linking material attributes, process parameters, and product performance

Regulatory & Lifecycle Support

• Serve as the quantitative lead supporting CMC regulatory submissions (IND, CTA, NDA, BLA, MAA) and lifecycle management activities

• Ensure statistical methodologies align with regulatory expectations and ICH guidelines (Q8, Q9, Q10, Q14)

• Support regulatory responses by providing clear, scientifically defensible interpretation of CMC data

Requirements:

• Bachelor's degree in Chemical Engineering and 12+ years of pharmaceutical industry experience OR

• Master's degree in Chemical Engineering and 10+ years of similar experience noted above OR

• PhD in in Chemical Engineering and 8+ years of similar experience noted above

• Extensive previous managerial experiences also required

• Demonstrated expertise in DoE, multivariate analysis, process characterization, statistical modeling, and data visualization

• Working knowledge of solid oral dosage formulation and manufacturing processes (e.g., granulation, blending, compression, coating); hands-on development experience preferred

• Experience supporting late-stage development and global regulatory submissions

• Proficiency with JMP, R, Python, or comparable statistical software

• Excellent collaboration, communication, and technical influencing skills

#LI-LS1

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.

The annual base salary we reasonably expect to pay is $163,400.00-$223,000.00.

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 35% of the earned base salary and eligibility to participate in our equity based long term incentive program.

• retirement savings plan (with company match)
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans