Principal Scientist, Pharmaceutical Development

Neurocrine Biosciencesis 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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons disease classic congenital adrenal hyperplasia hyperphagia in patients with 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 and follow the company onLinkedInX Facebook and YouTube. (*in collaboration with AbbVie)

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.

• 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 NBICMO/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

• 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 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 parenteral drug product 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

#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 dont line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $130800.00-$179000.00. Individual pay decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and 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.