Neurocrine Biosciences
Scientist / Sr. Scientist, Analytical Chemistry
Neurocrine Biosciences, San Diego, California, United States, 92189
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do:
Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X and Facebook . (*in collaboration with AbbVie) About the Role: Develops and executes instrumental methods of analysis for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials to develop assays based on new and existing methodologies. Responsible for coordinating and supporting day-to-day operations in an Analytical Development (AD) GMP lab. This role will focus mainly on GMP laboratory workflows. The person will also schedule all analytical instruments calibrations, maintenance and qualification activities. This role will ensure full compliance with GMP regulation and support continuous improvement of lab processes and equipment readiness. _ Your Contributions (include, but are not limited to):
Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials
Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
Serve as the primary point of contact for all instrument-related activities and maintain equipment inventory, calibration and service records in compliance with GMP regulations
Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies
With supervision and as appropriate, assists investigations for out of specification, out of trend, and/or anomalous results
Participates in internal and external audits as SME for lab instrumentation
Support training of GMP lab staff on procedures, GMP requirements and safety protocols
Coordinate daily lab operations
Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training
Provides detailed reviews of peer generated data as well as that generated from contracted service providers
Maintains the inventory of GMP laboratory consumables and clean glassware
Performs other duties as assigned
Requirements:
BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions
MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above
PhD in chemistry or closely related field and some industry or relevant experience a plus
Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation
Practical working knowledge of conducting HPLC analysis and troubleshooting
Some expertise in evaluating analytical data and drawing meaningful conclusions
Knowledge of cGMP expectations for laboratory records and quality systems
Ability to provide ideas for process improvements
Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
Strong knowledge of one scientific discipline
Good knowledge of scientific principles, methods and techniques
Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting
Strong computer skills
Good communications, problem-solving, analytical thinking skills
Detail oriented
Ability to meet deadlines
Good project management skills
#LI-OB1 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. _ The annual base salary we reasonably expect to pay is $88,000.00-$127,550.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. #J-18808-Ljbffr
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do:
Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X and Facebook . (*in collaboration with AbbVie) About the Role: Develops and executes instrumental methods of analysis for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials to develop assays based on new and existing methodologies. Responsible for coordinating and supporting day-to-day operations in an Analytical Development (AD) GMP lab. This role will focus mainly on GMP laboratory workflows. The person will also schedule all analytical instruments calibrations, maintenance and qualification activities. This role will ensure full compliance with GMP regulation and support continuous improvement of lab processes and equipment readiness. _ Your Contributions (include, but are not limited to):
Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials
Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
Serve as the primary point of contact for all instrument-related activities and maintain equipment inventory, calibration and service records in compliance with GMP regulations
Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies
With supervision and as appropriate, assists investigations for out of specification, out of trend, and/or anomalous results
Participates in internal and external audits as SME for lab instrumentation
Support training of GMP lab staff on procedures, GMP requirements and safety protocols
Coordinate daily lab operations
Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training
Provides detailed reviews of peer generated data as well as that generated from contracted service providers
Maintains the inventory of GMP laboratory consumables and clean glassware
Performs other duties as assigned
Requirements:
BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions
MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above
PhD in chemistry or closely related field and some industry or relevant experience a plus
Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation
Practical working knowledge of conducting HPLC analysis and troubleshooting
Some expertise in evaluating analytical data and drawing meaningful conclusions
Knowledge of cGMP expectations for laboratory records and quality systems
Ability to provide ideas for process improvements
Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
Strong knowledge of one scientific discipline
Good knowledge of scientific principles, methods and techniques
Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting
Strong computer skills
Good communications, problem-solving, analytical thinking skills
Detail oriented
Ability to meet deadlines
Good project management skills
#LI-OB1 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. _ The annual base salary we reasonably expect to pay is $88,000.00-$127,550.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. #J-18808-Ljbffr