Neurocrine Biosciences
Sr. Scientist, Analytical Development
Neurocrine Biosciences, San Diego, California, United States, 92189
Overview
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Sr. Scientist, Analytical Development
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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 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 Biosciences is 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 in mid- to late-phase clinical development. For three decades, we have applied our neuroscience insight to treat complex conditions and pursue medicines to ease the burden of debilitating diseases. For more information, visit neurocrine.com. About The Role Analytical project leader responsible for performing analytical chemistry research to develop assays based on new and existing methodologies. Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases). Develops, establishes and validates testing methodologies used to control raw materials, production intermediates, and final products. Establishes, validates and documents new or existing compound-specific methods. Conducts testing of analytical samples for the laboratory area, supports separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Works in a cGMP environment with a focus on safety and regulatory requirements. Your Contributions (include, but are not limited to) Act as an analytical project leader Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products for preclinical and clinical studies Develops and validates test methods for drug substances (API), intermediates and drug product Supports chemical development and formulation development Preformulation collaboration to Pharmaceutical Sciences Tests and provides a complete characterization of toxicology supplies Structural characterization of drug substance molecules and identification of impurities/degradants in API and drug product Audits and selects contract service providers to conduct GMP analytical testing Analytical technology transfer to CSP Overviews GMP analytical testing of clinical supplies by CSPs Facilitates and leads investigations for out of specification/out of trend results Prepares analytical sections of regulatory documents, protocols and reports Provides training and/or supervision to junior staff, as needed Other duties as assigned Requirements BS/BA degree in chemistry or closely related field with 5+ years of pharmaceutical analytical experience (methods development/validation for various active ingredients and/or dosage forms); supervisory or project management experience preferred MS/MA degree in chemistry or closely related field with 3+ years of relevant experience PhD or equivalent in chemistry or closely related field and relevant experience (may include postdoc) Effective report writing and oral presentation skills Excellent written and verbal communication skills Ability to build excellent working relationships and maintain confidentiality Strong problem-solving, analytical thinking, and cross-functional understanding related to drug development Understanding of regulatory requirements for drug product commercialization, NDA preparation and cGMP Working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD Ability to lead teams and train others, with strong project management skills Proficiency with laboratory equipment and software, and ability to work in a team Ability to meet multiple deadlines with high accuracy Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment and encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. Compensation & Benefits The annual base salary we reasonably expect to pay is $108,600.00-$157,350.00. Individual pay decisions depend on location, role complexity, duties, and experience. The position includes 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, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision) per plan terms. Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Neurocrine Biosciences. Get notified about new Analytical Scientist jobs in San Diego, CA. Related roles Scientist/Sr. Scientist, Analytical Development Production Chemist I (ISO/GMP/GLP environment) Scientist / Sr. Scientist, Analytical Chemistry Quality Control Chemist I
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Join to apply for the
Sr. Scientist, Analytical Development
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 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 Biosciences is 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 in mid- to late-phase clinical development. For three decades, we have applied our neuroscience insight to treat complex conditions and pursue medicines to ease the burden of debilitating diseases. For more information, visit neurocrine.com. About The Role Analytical project leader responsible for performing analytical chemistry research to develop assays based on new and existing methodologies. Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases). Develops, establishes and validates testing methodologies used to control raw materials, production intermediates, and final products. Establishes, validates and documents new or existing compound-specific methods. Conducts testing of analytical samples for the laboratory area, supports separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Works in a cGMP environment with a focus on safety and regulatory requirements. Your Contributions (include, but are not limited to) Act as an analytical project leader Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products for preclinical and clinical studies Develops and validates test methods for drug substances (API), intermediates and drug product Supports chemical development and formulation development Preformulation collaboration to Pharmaceutical Sciences Tests and provides a complete characterization of toxicology supplies Structural characterization of drug substance molecules and identification of impurities/degradants in API and drug product Audits and selects contract service providers to conduct GMP analytical testing Analytical technology transfer to CSP Overviews GMP analytical testing of clinical supplies by CSPs Facilitates and leads investigations for out of specification/out of trend results Prepares analytical sections of regulatory documents, protocols and reports Provides training and/or supervision to junior staff, as needed Other duties as assigned Requirements BS/BA degree in chemistry or closely related field with 5+ years of pharmaceutical analytical experience (methods development/validation for various active ingredients and/or dosage forms); supervisory or project management experience preferred MS/MA degree in chemistry or closely related field with 3+ years of relevant experience PhD or equivalent in chemistry or closely related field and relevant experience (may include postdoc) Effective report writing and oral presentation skills Excellent written and verbal communication skills Ability to build excellent working relationships and maintain confidentiality Strong problem-solving, analytical thinking, and cross-functional understanding related to drug development Understanding of regulatory requirements for drug product commercialization, NDA preparation and cGMP Working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD Ability to lead teams and train others, with strong project management skills Proficiency with laboratory equipment and software, and ability to work in a team Ability to meet multiple deadlines with high accuracy Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment and encourage you to apply even if your experience or qualifications don’t line up exactly with the job description. Compensation & Benefits The annual base salary we reasonably expect to pay is $108,600.00-$157,350.00. Individual pay decisions depend on location, role complexity, duties, and experience. The position includes 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, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision) per plan terms. Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Neurocrine Biosciences. Get notified about new Analytical Scientist jobs in San Diego, CA. Related roles Scientist/Sr. Scientist, Analytical Development Production Chemist I (ISO/GMP/GLP environment) Scientist / Sr. Scientist, Analytical Chemistry Quality Control Chemist I
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