Neurocrine Biosciences
Manager, Bioanalytical Regulatory
Neurocrine Biosciences, San Diego, California, United States, 92189
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Manager, Bioanalytical Regulatory
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Neurocrine Biosciences At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We are passionate about our people and aim to relieve suffering for people with great needs. About The Company
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We develop treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments and a robust pipeline in mid- to late-phase development across core therapeutic areas. For more information, visit neurocrine.com. Note: in collaboration with AbbVie. About The Role
Oversees multiple bioanalytical functions related to Drug Metabolism and Pharmacokinetics (DMPK) discovery and development support. Supports bioanalytical method development and sample analysis across multiple modalities in a non-GLP and/or GLP environment. Develops highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in various biological matrices; reproduces CRO-developed methods and performs non-regulated quantitative bioanalysis. Contributes to long-term strategic planning to enable growth and productivity of the bioanalytical efforts within the regulatory space. Acts as the primary point of contact for certain DMPK bioanalytical efforts and serves as a bioanalytical expert on preclinical and clinical teams, mentoring and supervising junior team members as needed. Your Contributions (include, But Not Limited To) Provide oversight of bioanalytical CROs to transfer, develop, and validate regulated (GLP/GCP) bioanalytical methods; ensure quality data and reports are delivered within timelines Initiate and manage contracts; coordinate activities with CROs in pharmacokinetics, toxicokinetics, dose formulation analysis, immunogenicity, and biomarkers Contribute to preparation or review of Clinical Study Reports and regulatory documents to support INDs, BLAs, RFMs, IRs; address regulatory queries Conduct CRO evaluation and selection; review SOPs; determine additional bioanalytical requirements; perform site visits and inspections Provide technical monitoring during method development, validation, and sample analysis; oversee method transfer between CROs; review validation reports and documentation Participate in or lead development of strategic project/group goals; lead projects and teams for PK/TK studies Develop and implement novel methodologies to characterize DMPK properties and exposures Act as a Bioanalytical representative on participating teams Oversee and interact with outsourcing partners for bioanalysis and dose formulation analysis for PK/TK studies; ensure partners meet contractual standards within budget Provide expert contribution in preparation and review of regulatory submissions Mentor and supervise junior team members Perform other duties as assigned Requirements
BS/BA degree in chemistry, biology, or related discipline; or 8+ years of hands-on experience with automation, tissue culture, LC-MS/MS; strong background in DMPK screening models (permeability and transporter models); experience acting as a DMPK representative on discovery teams; experience in an ADME laboratory is preferred Master's degree in chemistry/biology or related discipline with 6+ years of similar experience; OR PhD in chemistry/biology or related discipline with 3+ years of relevant experience (including postdoc may be considered) Extensive experience in DMPK core competencies (instrumental analysis, automation, GLP method development/validation, and new technology implementation) Expertise as a DMPK bioanalytical leader on discovery teams Hands-on experience with technology such as automation, LC-MS/MS, high-resolution MS, PK/TK analysis, and GLP method development/validation Expertise in small molecule bioanalysis, MS/MS, UHPLC, biological matrix processing, tissue homogenization, and automation Desirable expertise in high-resolution MS (ToF, Orbitrap, FT-ICR), microflow MS, peptide/protein bioanalysis by LC-MS, or ligand-binding assays Excellent written and verbal communication skills Knowledge of regulatory (GLP) bioanalysis guidance and experience guiding CROs for method development/validation; monitoring CRO deliverables for nonclinical and clinical studies Strong knowledge of scientific principles and laboratory instrumentation; adaptability to multiple programs and teams Ability to mentor and lead multiple teams; strong project management Excellent computer skills and problem-solving abilities Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to a workplace of belonging, respect, and empowerment and encourage applicants with diverse qualifications to apply. The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Bonus target is 30% of base salary with eligibility for equity-based long-term incentives. Benefits include a retirement plan with company match, paid vacation/holiday/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage. Seniority level
Mid-Senior level Employment type
Full-time Job function
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Manager, Bioanalytical Regulatory
role at
Neurocrine Biosciences At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We are passionate about our people and aim to relieve suffering for people with great needs. About The Company
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We develop treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments and a robust pipeline in mid- to late-phase development across core therapeutic areas. For more information, visit neurocrine.com. Note: in collaboration with AbbVie. About The Role
Oversees multiple bioanalytical functions related to Drug Metabolism and Pharmacokinetics (DMPK) discovery and development support. Supports bioanalytical method development and sample analysis across multiple modalities in a non-GLP and/or GLP environment. Develops highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in various biological matrices; reproduces CRO-developed methods and performs non-regulated quantitative bioanalysis. Contributes to long-term strategic planning to enable growth and productivity of the bioanalytical efforts within the regulatory space. Acts as the primary point of contact for certain DMPK bioanalytical efforts and serves as a bioanalytical expert on preclinical and clinical teams, mentoring and supervising junior team members as needed. Your Contributions (include, But Not Limited To) Provide oversight of bioanalytical CROs to transfer, develop, and validate regulated (GLP/GCP) bioanalytical methods; ensure quality data and reports are delivered within timelines Initiate and manage contracts; coordinate activities with CROs in pharmacokinetics, toxicokinetics, dose formulation analysis, immunogenicity, and biomarkers Contribute to preparation or review of Clinical Study Reports and regulatory documents to support INDs, BLAs, RFMs, IRs; address regulatory queries Conduct CRO evaluation and selection; review SOPs; determine additional bioanalytical requirements; perform site visits and inspections Provide technical monitoring during method development, validation, and sample analysis; oversee method transfer between CROs; review validation reports and documentation Participate in or lead development of strategic project/group goals; lead projects and teams for PK/TK studies Develop and implement novel methodologies to characterize DMPK properties and exposures Act as a Bioanalytical representative on participating teams Oversee and interact with outsourcing partners for bioanalysis and dose formulation analysis for PK/TK studies; ensure partners meet contractual standards within budget Provide expert contribution in preparation and review of regulatory submissions Mentor and supervise junior team members Perform other duties as assigned Requirements
BS/BA degree in chemistry, biology, or related discipline; or 8+ years of hands-on experience with automation, tissue culture, LC-MS/MS; strong background in DMPK screening models (permeability and transporter models); experience acting as a DMPK representative on discovery teams; experience in an ADME laboratory is preferred Master's degree in chemistry/biology or related discipline with 6+ years of similar experience; OR PhD in chemistry/biology or related discipline with 3+ years of relevant experience (including postdoc may be considered) Extensive experience in DMPK core competencies (instrumental analysis, automation, GLP method development/validation, and new technology implementation) Expertise as a DMPK bioanalytical leader on discovery teams Hands-on experience with technology such as automation, LC-MS/MS, high-resolution MS, PK/TK analysis, and GLP method development/validation Expertise in small molecule bioanalysis, MS/MS, UHPLC, biological matrix processing, tissue homogenization, and automation Desirable expertise in high-resolution MS (ToF, Orbitrap, FT-ICR), microflow MS, peptide/protein bioanalysis by LC-MS, or ligand-binding assays Excellent written and verbal communication skills Knowledge of regulatory (GLP) bioanalysis guidance and experience guiding CROs for method development/validation; monitoring CRO deliverables for nonclinical and clinical studies Strong knowledge of scientific principles and laboratory instrumentation; adaptability to multiple programs and teams Ability to mentor and lead multiple teams; strong project management Excellent computer skills and problem-solving abilities Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to a workplace of belonging, respect, and empowerment and encourage applicants with diverse qualifications to apply. The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Bonus target is 30% of base salary with eligibility for equity-based long-term incentives. Benefits include a retirement plan with company match, paid vacation/holiday/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Referrals increase your chances of interviewing at Neurocrine Biosciences. Sign in to set job alerts for “Regulatory Manager” roles.
#J-18808-Ljbffr