Sr. Scientist, Pharmaceutical Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Benefits offered by this job

Annual bonus

Equity incentives

Retirement savings plan

Health benefits

Job summary

Neurocrine Biosciences in San Diego is seeking a senior technical leader for Pharmaceutical Development, representing CMC across the product lifecycle from discovery to commercialization. You will provide strategic leadership in process development, material characterization, and analytical strategies to enable phase-appropriate development and regulatory objectives.

You will oversee CRO/CMO partnerships, support tech transfer, and lead cross-functional teams to deliver high-quality drug

Qualifications

• BS/BA in Chemistry, Biochemistry, Chemical Engineering, or related field with 6+ years pharma experience, or MS/MA with 4+ years, or PhD with 2+ years.
• Strong cGMP knowledge across early- and late-stage drug product manufacturing.
• Deep expertise in product development, including process design, scale-up, validation, and lifecycle management.
• Cross-functional understanding from discovery to commercialization including CMC strategy and regulatory lifecycle.

Responsibilities

• Provide scientific and technical leadership across drug product development from discovery to launch.
• Lead project team meetings, communicate progress and risks to leadership.
• Design and scale formulations and manufacturing processes using QbD and DoE.
• Lead process development activities including DoE, scale-up, validation, and tech transfer.
• Investigate complex issues across preformulation, formulation, analytical, and manufacturing; drive root-cause analysis.
• Collaborate with CDMOs and vendors to ensure capabilities, quality, and supply.
• Act as technical lead during manufacturing campaigns and on-site activities.

Skills

Leadership

Cross-functional

Analytical thinking

Project management

Regulatory knowledge

Education

BS/BA in Chemistry/Biochemistry/Chemical Engineering

MS/MA in Chemistry/Biochem/Chemical Eng

PhD in Chemistry/Biochemistry/ChE

Tools

cGMP systems

DoE

Process modeling

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:

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 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:

• 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 OR 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


• 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 & NDA


• 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:

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:

• 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.

EEO Statement:

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.

Company Values:

• PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.


• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.


• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent.


• INNOVATION: We seek and create optimal solutions.


• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!