Neurocrine Biosciences
Sr. Scientist, Bioanalytical
Neurocrine Biosciences, San Diego, California, United States, 92189
Overview
Who We Are: Neurocrine Biosciences is built on a strong, inclusive culture and a clear purpose: to relieve suffering for people with great needs. We value our people as much as our purpose and are committed to a positive, purpose-driven environment. About the Role
The Bioanalytical Senior Scientist, as part of the preclinical team, will develop and perform assays to quantify large molecule therapeutics in biological fluids and tissues using ligand binding assays (LBA). The qualified individual will implement assay platforms (e.g., ELISA, electrochemiluminescence) to answer questions related to pharmacokinetics, pharmacodynamics, and immunogenicity. This role suits a candidate with a strong foundation in bioanalytical analysis of biologics and experience in fit-for-purpose method development supporting regulated and non-regulated programs. Role scope includes collaboration with internal stakeholders, transfer of internal assays to support regulated preclinical studies, and execution of bioanalytical analyses for both regulated and non-regulated programs. Your Contributions (include, but are not limited to)
Lead the development and qualification of ADA assays (e.g., bridging electrochemiluminescence) to assess immunogenicity in biologic programs Collaborate with internal stakeholders to support CRO selection and oversee the transfer of internal assays for regulated preclinical studies Develop custom reagents and perform method development on platforms such as ELISA, electrochemiluminescence, and Gyros for PK and/or immunogenicity assessments Perform sample analysis to support bioanalysis efforts for non-regulated preclinical studies (PK, PD, immunogenicity, biological activity) Execute bioanalytical sample analysis using automated liquid handling platforms (e.g., Tecan, Hamilton, Beckman Coulter) Lead troubleshooting for both internal methods and CRO methods to ensure data quality Communicate results to internal/external teams in presentations and reports Prepare documents to support technical transfer of methods to CROs Manage and maintain a safe, organized laboratory space, including equipment maintenance and procurement of supplies May QC study reports and regulatory submissions Performs other duties as assigned Requirements
BS/BA in Biology or related field with 5+ years of industry experience in biotech/pharma/CRO settings; experience in a timeline-driven environment; preference for large molecule or biomarker bioanalysis MS/MA in Biology or related field with 3+ years of relevant experience PhD or equivalent with related experience or PostDoc work Degree in biology, chemistry, or related science, preferably with bioanalytical laboratory experience Core competencies in immunoassays (e.g., ELISA), handling serum/plasma, automation, GLP study method development/validation, and biomarker analysis Experience with automation and PK analysis/modeling software and hands-on with automated liquid handling systems Experience in cross-functional teams supporting drug development Strong written and verbal communication skills Knowledge of regulatory requirements for bioanalytical assays Experience generating immunoassay reagents and managing reagent life cycles Ability to recognize anomalous results and interpret outcomes Strong foundation in scientific principles and methods Ability to work with various laboratory instrumentation and PK analysis/modeled software Excellent computer skills and problem-solving abilities Ability to meet multiple deadlines with accuracy and efficiency #LI-OB1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment. We encourage applicants even if experience or qualifications do not exactly match the description. The annual base salary we reasonably expect to pay is $108,600.00–$157,350.00, with bonuses and equity incentives as described. Benefits include a 401(k) with company match, vacation, holidays, personal days, caregiver/parental and medical leave, and health, dental, and vision coverage.
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Who We Are: Neurocrine Biosciences is built on a strong, inclusive culture and a clear purpose: to relieve suffering for people with great needs. We value our people as much as our purpose and are committed to a positive, purpose-driven environment. About the Role
The Bioanalytical Senior Scientist, as part of the preclinical team, will develop and perform assays to quantify large molecule therapeutics in biological fluids and tissues using ligand binding assays (LBA). The qualified individual will implement assay platforms (e.g., ELISA, electrochemiluminescence) to answer questions related to pharmacokinetics, pharmacodynamics, and immunogenicity. This role suits a candidate with a strong foundation in bioanalytical analysis of biologics and experience in fit-for-purpose method development supporting regulated and non-regulated programs. Role scope includes collaboration with internal stakeholders, transfer of internal assays to support regulated preclinical studies, and execution of bioanalytical analyses for both regulated and non-regulated programs. Your Contributions (include, but are not limited to)
Lead the development and qualification of ADA assays (e.g., bridging electrochemiluminescence) to assess immunogenicity in biologic programs Collaborate with internal stakeholders to support CRO selection and oversee the transfer of internal assays for regulated preclinical studies Develop custom reagents and perform method development on platforms such as ELISA, electrochemiluminescence, and Gyros for PK and/or immunogenicity assessments Perform sample analysis to support bioanalysis efforts for non-regulated preclinical studies (PK, PD, immunogenicity, biological activity) Execute bioanalytical sample analysis using automated liquid handling platforms (e.g., Tecan, Hamilton, Beckman Coulter) Lead troubleshooting for both internal methods and CRO methods to ensure data quality Communicate results to internal/external teams in presentations and reports Prepare documents to support technical transfer of methods to CROs Manage and maintain a safe, organized laboratory space, including equipment maintenance and procurement of supplies May QC study reports and regulatory submissions Performs other duties as assigned Requirements
BS/BA in Biology or related field with 5+ years of industry experience in biotech/pharma/CRO settings; experience in a timeline-driven environment; preference for large molecule or biomarker bioanalysis MS/MA in Biology or related field with 3+ years of relevant experience PhD or equivalent with related experience or PostDoc work Degree in biology, chemistry, or related science, preferably with bioanalytical laboratory experience Core competencies in immunoassays (e.g., ELISA), handling serum/plasma, automation, GLP study method development/validation, and biomarker analysis Experience with automation and PK analysis/modeling software and hands-on with automated liquid handling systems Experience in cross-functional teams supporting drug development Strong written and verbal communication skills Knowledge of regulatory requirements for bioanalytical assays Experience generating immunoassay reagents and managing reagent life cycles Ability to recognize anomalous results and interpret outcomes Strong foundation in scientific principles and methods Ability to work with various laboratory instrumentation and PK analysis/modeled software Excellent computer skills and problem-solving abilities Ability to meet multiple deadlines with accuracy and efficiency #LI-OB1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment. We encourage applicants even if experience or qualifications do not exactly match the description. The annual base salary we reasonably expect to pay is $108,600.00–$157,350.00, with bonuses and equity incentives as described. Benefits include a 401(k) with company match, vacation, holidays, personal days, caregiver/parental and medical leave, and health, dental, and vision coverage.
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