Neurocrine Biosciences
Scientist/Sr. Scientist, Analytical Development
Neurocrine Biosciences, San Diego, California, United States, 92189
Overview
Scientist/Sr. Scientist, Analytical Development at Neurocrine Biosciences. The role involves performing analytical development for small molecule pharmaceuticals and supporting manufacturing of drug products for clinical studies, developing and validating testing methodologies, establishing compound-specific methods, and ensuring cGMP compliance. Responsibilities
Responsible for in-house analytical development laboratory activities to support manufacturing of drug products intended for use in clinical studies Responsible for conducting in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.) Work closely with Pharmaceutical Development counterparts Develops and validates test methods at NBI for solid oral drug products Supports formulation development Identification of degradants in drug product Analytical technology transfer to CSP Overviews GMP analytical testing of clinical supplies by CSPs Facilitates and leads investigations for out of specification and out of trend results Prepares the 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 and 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry. Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms. Previous supervisory and/or project management experience is preferred MS/MA degree in chemistry or closely related field and 3+ years of similar experience in the pharmaceutical industry PhD or equivalent in chemistry or closely related field with some relevant experience; may include postdoc experience Effective report writing and oral presentation skills are required Excellent written and verbal communication skills are required Must be able to build excellent working relationships and maintain confidentiality regarding intellectual property and proprietary endeavors of the company Ability to creatively solve complex problems in a team environment Demonstration of cross-functional understanding related to drug development Ability to see projects to completion Understanding of how to negotiate, persuade, and influence Extensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms Working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of QA/QC practices and issues Working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD Solid understanding of HPLC analytical development and/or dissolution development Laboratory documentation in line with cGMP practices Ability to work as part of a team and to lead teams Excellent computer skills Strong communication, problem-solving, and analytical thinking skills Detail oriented with the ability to see the broader impact of the scientific work Ability to meet multiple deadlines with a high degree of accuracy and efficiency Strong project management skills Compensation and Benefits
The annual base salary range is $108,600.00 – $157,350.00. Individual pay decisions depend on factors such as primary work location, role responsibilities, and relevant experience. The position includes an annual bonus target of 20% of base salary and eligibility to participate in the company\'s equity-based long-term incentive program. Benefits include a retirement savings plan with company match, paid vacation, holidays, personal days, caregiver/ parental and medical leave, and health benefits (medical, prescription drug, dental, and vision) in accordance with the terms and conditions of the applicable plans. Location: San Diego, CA 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.
#J-18808-Ljbffr
Scientist/Sr. Scientist, Analytical Development at Neurocrine Biosciences. The role involves performing analytical development for small molecule pharmaceuticals and supporting manufacturing of drug products for clinical studies, developing and validating testing methodologies, establishing compound-specific methods, and ensuring cGMP compliance. Responsibilities
Responsible for in-house analytical development laboratory activities to support manufacturing of drug products intended for use in clinical studies Responsible for conducting in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.) Work closely with Pharmaceutical Development counterparts Develops and validates test methods at NBI for solid oral drug products Supports formulation development Identification of degradants in drug product Analytical technology transfer to CSP Overviews GMP analytical testing of clinical supplies by CSPs Facilitates and leads investigations for out of specification and out of trend results Prepares the 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 and 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry. Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms. Previous supervisory and/or project management experience is preferred MS/MA degree in chemistry or closely related field and 3+ years of similar experience in the pharmaceutical industry PhD or equivalent in chemistry or closely related field with some relevant experience; may include postdoc experience Effective report writing and oral presentation skills are required Excellent written and verbal communication skills are required Must be able to build excellent working relationships and maintain confidentiality regarding intellectual property and proprietary endeavors of the company Ability to creatively solve complex problems in a team environment Demonstration of cross-functional understanding related to drug development Ability to see projects to completion Understanding of how to negotiate, persuade, and influence Extensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms Working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of QA/QC practices and issues Working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD Solid understanding of HPLC analytical development and/or dissolution development Laboratory documentation in line with cGMP practices Ability to work as part of a team and to lead teams Excellent computer skills Strong communication, problem-solving, and analytical thinking skills Detail oriented with the ability to see the broader impact of the scientific work Ability to meet multiple deadlines with a high degree of accuracy and efficiency Strong project management skills Compensation and Benefits
The annual base salary range is $108,600.00 – $157,350.00. Individual pay decisions depend on factors such as primary work location, role responsibilities, and relevant experience. The position includes an annual bonus target of 20% of base salary and eligibility to participate in the company\'s equity-based long-term incentive program. Benefits include a retirement savings plan with company match, paid vacation, holidays, personal days, caregiver/ parental and medical leave, and health benefits (medical, prescription drug, dental, and vision) in accordance with the terms and conditions of the applicable plans. Location: San Diego, CA 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.
#J-18808-Ljbffr