Neurocrine Biosciences
Sr. Scientist/Principal Scientist, Analytical Development
Neurocrine Biosciences, San Diego, California, United States, 92189
Sr. Scientist/Principal Scientist, Analytical Development
Overview
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. About The Role
This position will serve as the SME for separation method development and analytical development lead for multiple projects, with a focus on antibodies and bio-conjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify separation methods used to control in process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects. Your Contributions
Lead separation analytical method development and validation/qualification activities for the characterization of antibodies and/or bio-conjugates utilizing advanced separation techniques (e.g. SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, etc.) within cGMP compliance in support of preclinical through commercialization Represent Analytical Development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects Direct laboratory work and/or lab personnel within the company and at external vendors Ensure laboratory safety practices Support off-site analytical method transfers, manufacturing support, and interaction with external vendors Provide inputs into CMC regulatory documentation and supporting work Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC strategies Contribute to development of policies and department strategies Build and enhance internal and external professional relationships Support career development and technical growth of team members Present findings at varying levels across the company Other duties as assigned Requirements
BS/BA in Analytical Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 10+ years of experience OR PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience Expert knowledge and understanding of analytical chemistry, separation sciences, and a thorough understanding of bioprocess as well as formulation development Extensive experience and expertise with antibody and bio-conjugate modalities compounds, focusing on analytical development and separation method development Excellent interpersonal skills with strong oral and written communication abilities Excellent laboratory and productivity skills Proficient in characterization of antibody and bio-conjugate modalities using various modern technologies. They may include but not limited to size exclusion liquid chromatography, reverse phase liquid chromatography, hydrophilic interaction liquid chromatography, ion exchange liquid chromatography, hydrophobic interaction liquid chromatography, mixed mode liquid chromatography, UPLC/HPLC, capillary electrophoresis (Maurice/PA800+), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, and molecular analysis Method development, validation, qualification, and transfer experience in Analytical Development Comprehensive understanding of cGMP requirements in drug substance and drug product Expert knowledge of cross-functional understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements 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. Compensation and Benefits
The annual base salary we reasonably expect to pay is $128,200-$185,900. Individual pay decisions depend on location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. This position offers an annual bonus with a target of 30% of base salary and eligibility to participate in our equity-based long-term incentive program. Benefits include retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/ parental and medical leave, and health benefits (medical, prescription drug, dental and vision) per plan terms. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology
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Overview
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. About The Role
This position will serve as the SME for separation method development and analytical development lead for multiple projects, with a focus on antibodies and bio-conjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify separation methods used to control in process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects. Your Contributions
Lead separation analytical method development and validation/qualification activities for the characterization of antibodies and/or bio-conjugates utilizing advanced separation techniques (e.g. SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, etc.) within cGMP compliance in support of preclinical through commercialization Represent Analytical Development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects Direct laboratory work and/or lab personnel within the company and at external vendors Ensure laboratory safety practices Support off-site analytical method transfers, manufacturing support, and interaction with external vendors Provide inputs into CMC regulatory documentation and supporting work Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC strategies Contribute to development of policies and department strategies Build and enhance internal and external professional relationships Support career development and technical growth of team members Present findings at varying levels across the company Other duties as assigned Requirements
BS/BA in Analytical Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 10+ years of experience OR PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience Expert knowledge and understanding of analytical chemistry, separation sciences, and a thorough understanding of bioprocess as well as formulation development Extensive experience and expertise with antibody and bio-conjugate modalities compounds, focusing on analytical development and separation method development Excellent interpersonal skills with strong oral and written communication abilities Excellent laboratory and productivity skills Proficient in characterization of antibody and bio-conjugate modalities using various modern technologies. They may include but not limited to size exclusion liquid chromatography, reverse phase liquid chromatography, hydrophilic interaction liquid chromatography, ion exchange liquid chromatography, hydrophobic interaction liquid chromatography, mixed mode liquid chromatography, UPLC/HPLC, capillary electrophoresis (Maurice/PA800+), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, and molecular analysis Method development, validation, qualification, and transfer experience in Analytical Development Comprehensive understanding of cGMP requirements in drug substance and drug product Expert knowledge of cross-functional understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements 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. Compensation and Benefits
The annual base salary we reasonably expect to pay is $128,200-$185,900. Individual pay decisions depend on location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. This position offers an annual bonus with a target of 30% of base salary and eligibility to participate in our equity-based long-term incentive program. Benefits include retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/ parental and medical leave, and health benefits (medical, prescription drug, dental and vision) per plan terms. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology
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