Manager – Bioanalytical Regulatory

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)

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.



About the Role:

Oversees multiple bioanalytical functions at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Experience supporting bioanalytical method development, validation, and sample analysis across multiple modalities in a non-GLP and/or GLP environment. Responsible for overseeing thedevelopment and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in a variety of biological matrices at CROs.-. Contribute to long-term strategic planning to enable the growth and enhance productivity of the bioanalytical efforts within the regulatory space. Act as primary point of contact for certain DMPK bioanalytical efforts. Serve as a bioanalytical Subject Matter Expert (SME) on preclinical and clinical teams, and provide mentorship to and frequently supervise the day-to-day work of junior team members.

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

• Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines

• Initiate and manage contracts, coordinate activities with select CROs in the areas of pharmacokinetics, toxicokinetics, dose formulation analysis, immunogenicity, and biomarker

• Contribute to the preparation or review of study protocols, Clinical Study Reports and regulatory documents and interactions to support INDs, BLAs, RFMs, IRs and address relevant queries from regulatory agencies

• Conduct CRO evaluation and selection, review CRO SOPs, determine additional bioanalytical requirements as needed, and perform regular site visits and inspection

• Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs; reviewing validation reports and experimental documentation; and archiving relevant study documents

• Participates in or leads the development of strategic project / group goals, practices and methods

• Leads projects and teams for the analysis of in-vivo and ex-vivo studies to support pharmacokinetics(PK) and toxicokinetics (TK) studies

• Develops and implements novel methodologies to characterize DMPK properties and exposures of drug candidates and/or biomarkers

• Acts as a Bioanalytical representative on participating teams

• Oversees and interacts with outsourcing partners for bioanalysis and dose formulation analysis for PK and TK studies, ensures partners adhere to contractual standards within budget

• Provides expert level contribution in the preparation and review of regulatory submissions

• Will provide mentorship to and supervise junior team members

• Performs other duties as assigned

Requirements:

• BS/BA degree in chemistry/biology or a related discipline and 8+ years of hands-on experience with automation,  LC-MS/MS, LC/UV, enzyme- or immune-based assays. Strong background in method development/validation and regulated bioanalysis OR

• Master's degree in chemistry/biology or a related discipline and 6+ years of similar experience noted above OR

• PhD in chemistry/biology or a related discipline and 3+ years of relevant experience; may include postdoc experience

• Expertise acting as a bioanalytical SME and representative on discovery teams

• Extensive hands-on experience with role-appropriate technology and methodology such as: automation, LC-MS/MS, high resolution mass spectrometry, low-flow (microflow) mass spectrometry, enzyme- or immune-based assays, PK/TK analysis, GLP method development and validation

• Desired expertise in high resolution mass spectrometry (ToF, Orbitrap, or FT-ICR), low-flow (microflow) electrospray mass spectrometry, peptide and protein bioanalysis procedure using LC-MS, or ligand-binding assay for peptides and proteins

• Excellent written and verbal communication skills

• Knowledge in regulatory (GLP) bioanalysis guidance and whitepapers, and general regulatory practice, as well as experience in guiding CROs for method development and validation, and monitoring CROs deliverable for supporting nonclinical and clinical studies are desirable

• Expert knowledge of scientific principles, methods and techniques

• Expert knowledge and demonstrated ability working with a variety of laboratory instrumentation, automation, GLP method development and validation and/or PK/TK analysis

• Assimilates data and research findings outside of Neurocrine for application to new scientific projects

• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas

• May develop an understanding of other areas and related dependencies

• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple programs, teams and/or departments

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management skills

• Ability to mentor and direct the day-to-day work of less experienced team members

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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.

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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.