Neurocrine Biosciences
Scientist, Analytical Development
Neurocrine Biosciences, San Diego, California, United States, 92189
About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company focused on relieving suffering for people with great needs. We pursue medicines for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with a robust pipeline in mid- to late-phase development. For more information, visit neurocrine.com.
About The Role
Analytical scientist is responsible for performing analytical development based on new and existing methodologies for small molecule pharmaceuticals. Responsible for performing analytical laboratory activities to support manufacturing of drug products intended for use in clinical studies (all phases). Develops, establishes, and validates testing methodology used to control final drug products. Establishes, validates, and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus on safety and regulatory requirements. *
Your Contributions (include, But Are Not Limited To)
Develops and executes instrumental methods (e.g. HPLC, dissolution) to support manufacturing of drug products intended for use in clinical studies
Conducts in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.)
Follows established test methods, procedures, regulatory guidance (e.g. ICH), and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
Plans and executes laboratory testing of in-house analytical method development activities, analytical method validation, stability studies for drug products, and formulation development support (with supervision and independently)
Assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results (with supervision)
Collaboratively plans and executes cross-functional studies for chemical development and formulation development (with supervision)
Recognizes fundamental anomalies in data points, inconsistent results, and identifies issues in experiments/processes
Interprets experimental outcomes and communicates results to the broader team
Creates and reviews technical reports and oral presentations of various analytical activities (e.g. method development reports, investigations, results summaries)
Maintains complete and accurate records of laboratory work in conformance with SOPs, GxP expectations, and training
Provides detailed reviews of peer-generated data as well as data from contracted service providers
Performs other duties as assigned
Requirements
BS/BA in chemistry or closely related field with 2+ years of pharmaceutical industry experience in an R&D/QC setting, including HPLC analysis and troubleshooting, evaluating analytical data, and drawing meaningful conclusions
MS/MA in chemistry or closely related field preferred with similar industry experience
PhD in chemistry or closely related field and some industry or relevant experience a plus
Effective report writing and oral presentation skills required
Excellent written and verbal communication skills required
Ability to build excellent working relationships and maintain confidentiality regarding IP and proprietary endeavors
Demonstration of cross-functional understanding related to drug development
Practical working knowledge of HPLC analysis and troubleshooting
Ability to evaluate analytical data and draw meaningful conclusions
Knowledge of cGMP expectations for laboratory records and quality systems
Ability to propose process improvements
Ability to think beyond the technical process and consider broader scientific goals
Good knowledge of scientific principles, methods, and techniques
Experience with laboratory equipment such as HPLC, USP dissolution apparatus, and Karl Fischer
Ability to work collaboratively in a team to meet goals and timelines
Strong computer skills, problem-solving and analytical thinking
Detail-oriented with ability to see the broader scientific impact on the team
Ability to meet multiple deadlines with accuracy and efficiency
Strong project management skills
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. *
Compensation and Benefits
The annual base salary we reasonably expect to pay is $88,000.00-$127,550.00. Individual pay decisions depend on factors such as location, role complexity and responsibilities, and relevant experience. This position offers an annual bonus target of 20% of base salary and eligibility for our equity-based long-term incentive program. Benefits include a retirement savings plan with company match, paid vacation, holidays and personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental, vision) per applicable plan terms.
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Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company focused on relieving suffering for people with great needs. We pursue medicines for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with a robust pipeline in mid- to late-phase development. For more information, visit neurocrine.com.
About The Role
Analytical scientist is responsible for performing analytical development based on new and existing methodologies for small molecule pharmaceuticals. Responsible for performing analytical laboratory activities to support manufacturing of drug products intended for use in clinical studies (all phases). Develops, establishes, and validates testing methodology used to control final drug products. Establishes, validates, and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus on safety and regulatory requirements. *
Your Contributions (include, But Are Not Limited To)
Develops and executes instrumental methods (e.g. HPLC, dissolution) to support manufacturing of drug products intended for use in clinical studies
Conducts in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.)
Follows established test methods, procedures, regulatory guidance (e.g. ICH), and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
Plans and executes laboratory testing of in-house analytical method development activities, analytical method validation, stability studies for drug products, and formulation development support (with supervision and independently)
Assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results (with supervision)
Collaboratively plans and executes cross-functional studies for chemical development and formulation development (with supervision)
Recognizes fundamental anomalies in data points, inconsistent results, and identifies issues in experiments/processes
Interprets experimental outcomes and communicates results to the broader team
Creates and reviews technical reports and oral presentations of various analytical activities (e.g. method development reports, investigations, results summaries)
Maintains complete and accurate records of laboratory work in conformance with SOPs, GxP expectations, and training
Provides detailed reviews of peer-generated data as well as data from contracted service providers
Performs other duties as assigned
Requirements
BS/BA in chemistry or closely related field with 2+ years of pharmaceutical industry experience in an R&D/QC setting, including HPLC analysis and troubleshooting, evaluating analytical data, and drawing meaningful conclusions
MS/MA in chemistry or closely related field preferred with similar industry experience
PhD in chemistry or closely related field and some industry or relevant experience a plus
Effective report writing and oral presentation skills required
Excellent written and verbal communication skills required
Ability to build excellent working relationships and maintain confidentiality regarding IP and proprietary endeavors
Demonstration of cross-functional understanding related to drug development
Practical working knowledge of HPLC analysis and troubleshooting
Ability to evaluate analytical data and draw meaningful conclusions
Knowledge of cGMP expectations for laboratory records and quality systems
Ability to propose process improvements
Ability to think beyond the technical process and consider broader scientific goals
Good knowledge of scientific principles, methods, and techniques
Experience with laboratory equipment such as HPLC, USP dissolution apparatus, and Karl Fischer
Ability to work collaboratively in a team to meet goals and timelines
Strong computer skills, problem-solving and analytical thinking
Detail-oriented with ability to see the broader scientific impact on the team
Ability to meet multiple deadlines with accuracy and efficiency
Strong project management skills
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. *
Compensation and Benefits
The annual base salary we reasonably expect to pay is $88,000.00-$127,550.00. Individual pay decisions depend on factors such as location, role complexity and responsibilities, and relevant experience. This position offers an annual bonus target of 20% of base salary and eligibility for our equity-based long-term incentive program. Benefits include a retirement savings plan with company match, paid vacation, holidays and personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental, vision) per applicable plan terms.
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