Manager, Bioanalytical Regulatory

Neurocrine Biosciences • San Diego, CA

7d • $130,800 - $179,000 • Onsite

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company 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 and a robust pipeline. Neurocrine seeks leaders who think strategically, anticipate what's ahead, and set clear direction while building and empowering high-performing teams. This role oversees multiple bioanalytical functions at contract research organizations (CROs) according to project-relevant regulatory requirements and industry standards. The position requires experience supporting bioanalytical method development, validation, and sample analysis across multiple modalities in a non-GLP and/or GLP environment. The role is responsible for overseeing the development and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in various biological matrices at CROs. The position also contributes to long-term strategic planning to enable growth and enhance productivity of bioanalytical efforts within the regulatory space, acts as a primary point of contact for certain DMPK bioanalytical efforts, and serves as a bioanalytical Subject Matter Expert (SME) on preclinical and clinical teams, providing mentorship and supervision to junior team members.

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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager