Neurocrine Biosciences
TEMP - Scientist, Bioanalytical Outsourcing
Neurocrine Biosciences, San Diego, California, United States, 92101
About The Role
Oversees multiple aspects of bioanalysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Establish contracts and work orders for bioanalytical projects. Plan and track bioanalytical method development, validation, and sample analysis to support GLP toxicology studies. Individual will possess project management skills and will have strong knowledge in at least one bioanalytical core competency (LC/MS/MS, LC/UV, automation, method development/validation, GLPs, enzyme- or immuno-based assays). Your Contributions (Include, But Are Not Limited To):
Support all aspects of bioanalytical and dose formulation outsourcing (custom reagent preparation, method development, validation, and sample analysis) at bioanalytical CROs according to regulatory requirements and industry standards for both small and large molecules
Ensure CROs are provided with requisite supplies and information for assay development and sample analysis
Work with CMC to schedule for reference standard internal standard synthesis, and to plan for certificate of analysis generation and recertification
Review validation and study protocols, sample analysis plans, bioanalytical and dose formulation data and reports to ensure regulatory alignment
Plan and track bioanalytical and dose formulation method development, validation and sample analysis activities to meet data requirements in accordance with study protocols and project deliverables
Attend regular meetings with CROs to obtain study updates. Capture important expectations and agreed to tasks in post-meeting minutes, share minutes with CROs and relevant NBI personnel
Work with R&D Strategy and Operations to establish contracts and work orders for bioanalytical projects
Provide routine status updates to NBI stakeholders: Toxicology, Pharmacokinetics, Finance and R&D Strategy and Operations
Other tasks as assigned
Requirements:
BS/BA degree in science related field or similar and 2+ years of pharmaceutical/biotech experience. Experience in managing clinical Contract Research Organizations, preparation of INDs, CTDs, NDAs, and MAAs and working in a cross functional team and matrix environment. Experience developing small/large molecule compounds for CNS indications and silico modeling and simulation tools is beneficial OR
MS/MA degree in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 1+ years of similar experience noted above
Experience supporting the development, validation, and troubleshooting of bioanalytical methods and sample analysis in one or more of the following disciplines: small molecule, peptides, antibodies, and gene therapy
Knowledgeable on current regulatory guidance/regulations (FDA/ICH M10)
Demonstrates solid level of understanding project/group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Moderate knowledge of scientific principles, methods and techniques in small or large molecule bioanalysis
Detail oriented yet can see broader picture of scientific impact on team
Strong project management skills
Excellent computer skills
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management skills
Excellent problem-solving and analytical thinking skills
Strong written, presentation, and verbal communication skills
Proactive, innovative, with good problem-solving skills
Ability to work as part of a team
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.
Oversees multiple aspects of bioanalysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Establish contracts and work orders for bioanalytical projects. Plan and track bioanalytical method development, validation, and sample analysis to support GLP toxicology studies. Individual will possess project management skills and will have strong knowledge in at least one bioanalytical core competency (LC/MS/MS, LC/UV, automation, method development/validation, GLPs, enzyme- or immuno-based assays). Your Contributions (Include, But Are Not Limited To):
Support all aspects of bioanalytical and dose formulation outsourcing (custom reagent preparation, method development, validation, and sample analysis) at bioanalytical CROs according to regulatory requirements and industry standards for both small and large molecules
Ensure CROs are provided with requisite supplies and information for assay development and sample analysis
Work with CMC to schedule for reference standard internal standard synthesis, and to plan for certificate of analysis generation and recertification
Review validation and study protocols, sample analysis plans, bioanalytical and dose formulation data and reports to ensure regulatory alignment
Plan and track bioanalytical and dose formulation method development, validation and sample analysis activities to meet data requirements in accordance with study protocols and project deliverables
Attend regular meetings with CROs to obtain study updates. Capture important expectations and agreed to tasks in post-meeting minutes, share minutes with CROs and relevant NBI personnel
Work with R&D Strategy and Operations to establish contracts and work orders for bioanalytical projects
Provide routine status updates to NBI stakeholders: Toxicology, Pharmacokinetics, Finance and R&D Strategy and Operations
Other tasks as assigned
Requirements:
BS/BA degree in science related field or similar and 2+ years of pharmaceutical/biotech experience. Experience in managing clinical Contract Research Organizations, preparation of INDs, CTDs, NDAs, and MAAs and working in a cross functional team and matrix environment. Experience developing small/large molecule compounds for CNS indications and silico modeling and simulation tools is beneficial OR
MS/MA degree in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 1+ years of similar experience noted above
Experience supporting the development, validation, and troubleshooting of bioanalytical methods and sample analysis in one or more of the following disciplines: small molecule, peptides, antibodies, and gene therapy
Knowledgeable on current regulatory guidance/regulations (FDA/ICH M10)
Demonstrates solid level of understanding project/group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Moderate knowledge of scientific principles, methods and techniques in small or large molecule bioanalysis
Detail oriented yet can see broader picture of scientific impact on team
Strong project management skills
Excellent computer skills
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management skills
Excellent problem-solving and analytical thinking skills
Strong written, presentation, and verbal communication skills
Proactive, innovative, with good problem-solving skills
Ability to work as part of a team
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.