Manager, Bioanalytical Regulatory

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• 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 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

• BS/BA degree in chemistry/biology or a related discipline and

  8+ years of hands-on experience with automation, tissue culture, LC-MS/MS. Strong background in DMPK screening models, particularly permeability and transporter models. Experience acting as a DMPK representative on discovery teams. Experience in an ADME laboratory is preferred 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

• Extensive background in DMPK job-relevant core competency (instrumental analysis, automation, GLP method development and validation, new technology implementation )

• Expertise acting as a DMPK bioanalytical leader 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, PK/TK analysis, GLP method development and validation

• Expertise in small molecule bioanalysis, triple quadrupole mass spectrometry, ultra-high performance liquid chromatography, LC-MS/MS, biological matrix sample processing, tissue homogenization and automation

• 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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