Neurocrine Biosciences
Principal Scientist, Prod Dev - Late Stg
Neurocrine Biosciences, San Diego, California, United States, 92154
Overview Who We Are: At Neurocrine Biosciences, we pride ourselves on a strong, inclusive and positive culture based on our shared purpose and values. We are 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 dedicated to discovering and developing life-changing treatments for patients with 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, and a robust pipeline in mid- to late-phase development. For three decades we apply our neuroscience insights to treat complex conditions and pursue medicines to ease the burden of debilitating diseases. For more information, please visit neurocrine.com and follow us on LinkedIn, X, and Facebook.
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About the Role: Design, develop and execute formulation and process design & engineering to support development projects from Phase I through commercial. Manage, with a Quality by Design (QbD) mindset, full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, process development, scale-up engineering and optimization, packaging and stability testing of oral solid drug products. Implement innovative formulation strategies and robust process engineering to ensure product quality, scalability and regulatory compliance. Establish CDMO relationships to support clinical programs. Oversee successful technical transfer for Neurocrine drug products to CDMOs. Represent CMC within project teams to deliver high-quality, phase-appropriate drug products addressing molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile. Your Contributions
Design and develop robust formulations for solid oral dosage forms (e.g., tablets, capsules), optimizing for stability, bioavailability and manufacturability using QbD principles Develop and optimize manufacturing processes, including powder mixing/blending, granulation, compression, coating and encapsulation to define CQAs and CPPs Lead formulation and process scale up from lab scale to pivotal and commercial scales ensuring seamless technology transfer to CMO partner sites Participate and/or lead weekly or bi-weekly NBI-CMO project team meetings and inform stakeholders of progress, resource gaps and timelines Author and review Module 3 sections of drug product to support regulatory submissions Participate and/or lead investigations as a SME on atypical or aberrant results from pre-formulation through to commercial Identify and evaluate outsourcing partners with required expertise, capabilities, and quality/compliance standards to support drug product development and manufacturing with commercialization in sight Support Continuous Process Improvement (CPI) and CPV for commercial products, including troubleshooting and site redundancy efforts Research new instrumentation, equipment, and formulation/process technologies to be implemented for development of target formulations Present updates at department meetings and deliver scientific talks on current and new techniques/technology in formulation and process development Collaborate with Product Development Early Stage, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain teams and external/CDMO partners to advance projects from Phase IIb through commercial launch Participate in purchase, installation and maintenance of DP Pilot Plant laboratory equipment and instrumentation as needed; lead/train/mentor department members in use Author development reports, protocols, memos, specifications, and other relevant documentation for efficient access and retrieval Review CMC regulatory documents, batch records, specifications, development protocols, and product development reports for scientific integrity and regulatory compliance Represent Product Development as a "person-in-plant" during manufacturing campaigns and onsite meetings, as an exemplary ambassador of Neurocrine Other duties as assigned Requirements
BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of pharma late-stage product development experience; solid dosage form development from pre-formulation through validation; experience with QbD, DoE, and CRO/CMO management Master's degree in a related field with 6+ years of similar experience; or PhD with 4+ years of similar experience Thorough understanding of cGMP for drug product manufacturing, regulatory guidelines, and strong quality mindset Expert knowledge and hands-on experience in solid oral dosage formulations and related manufacturing unit operations for small molecules Expert level experience using statistical analysis software and risk assessment tools to implement QbD elements during product life cycle Ability to analyze data sets, identify trends, and make data-driven decisions to optimize outcomes Advanced knowledge of ICH, FDA, EMA guidance in CMC and Quality areas Cross-functional understanding related to drug development and strong collaboration skills Familiarity with analytical methods, validation, technology transfers and stability programs Accountability, target setting and results articulation Strong understanding of cGMPs relating to late-stage drug product manufacturing Expert knowledge of conventional solid oral dosage form manufacturing equipment (mixers, blenders, mills, granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc.) Knowledge of instrumentation and techniques such as HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, SEM Ability to assimilate external data/research for new scientific projects and maintain broad knowledge of scientific principles Ability to lead multiple teams and exhibit leadership and project management skills Excellent computer and communication skills, problem-solving and analytical thinking Ability to meet multiple deadlines across projects with high accuracy and efficiency Excellent project management skills EEO/Disability/Vets employer. We are committed to a workplace of belonging, respect, and empowerment and encourage applicants from diverse backgrounds. The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on location, role complexity, and relevant experience. The position includes an annual bonus target of 30% of base salary and eligibility for equity-based long-term incentives. Benefits include retirement plan with company match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
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Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity
About the Role: Design, develop and execute formulation and process design & engineering to support development projects from Phase I through commercial. Manage, with a Quality by Design (QbD) mindset, full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, process development, scale-up engineering and optimization, packaging and stability testing of oral solid drug products. Implement innovative formulation strategies and robust process engineering to ensure product quality, scalability and regulatory compliance. Establish CDMO relationships to support clinical programs. Oversee successful technical transfer for Neurocrine drug products to CDMOs. Represent CMC within project teams to deliver high-quality, phase-appropriate drug products addressing molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile. Your Contributions
Design and develop robust formulations for solid oral dosage forms (e.g., tablets, capsules), optimizing for stability, bioavailability and manufacturability using QbD principles Develop and optimize manufacturing processes, including powder mixing/blending, granulation, compression, coating and encapsulation to define CQAs and CPPs Lead formulation and process scale up from lab scale to pivotal and commercial scales ensuring seamless technology transfer to CMO partner sites Participate and/or lead weekly or bi-weekly NBI-CMO project team meetings and inform stakeholders of progress, resource gaps and timelines Author and review Module 3 sections of drug product to support regulatory submissions Participate and/or lead investigations as a SME on atypical or aberrant results from pre-formulation through to commercial Identify and evaluate outsourcing partners with required expertise, capabilities, and quality/compliance standards to support drug product development and manufacturing with commercialization in sight Support Continuous Process Improvement (CPI) and CPV for commercial products, including troubleshooting and site redundancy efforts Research new instrumentation, equipment, and formulation/process technologies to be implemented for development of target formulations Present updates at department meetings and deliver scientific talks on current and new techniques/technology in formulation and process development Collaborate with Product Development Early Stage, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain teams and external/CDMO partners to advance projects from Phase IIb through commercial launch Participate in purchase, installation and maintenance of DP Pilot Plant laboratory equipment and instrumentation as needed; lead/train/mentor department members in use Author development reports, protocols, memos, specifications, and other relevant documentation for efficient access and retrieval Review CMC regulatory documents, batch records, specifications, development protocols, and product development reports for scientific integrity and regulatory compliance Represent Product Development as a "person-in-plant" during manufacturing campaigns and onsite meetings, as an exemplary ambassador of Neurocrine Other duties as assigned Requirements
BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of pharma late-stage product development experience; solid dosage form development from pre-formulation through validation; experience with QbD, DoE, and CRO/CMO management Master's degree in a related field with 6+ years of similar experience; or PhD with 4+ years of similar experience Thorough understanding of cGMP for drug product manufacturing, regulatory guidelines, and strong quality mindset Expert knowledge and hands-on experience in solid oral dosage formulations and related manufacturing unit operations for small molecules Expert level experience using statistical analysis software and risk assessment tools to implement QbD elements during product life cycle Ability to analyze data sets, identify trends, and make data-driven decisions to optimize outcomes Advanced knowledge of ICH, FDA, EMA guidance in CMC and Quality areas Cross-functional understanding related to drug development and strong collaboration skills Familiarity with analytical methods, validation, technology transfers and stability programs Accountability, target setting and results articulation Strong understanding of cGMPs relating to late-stage drug product manufacturing Expert knowledge of conventional solid oral dosage form manufacturing equipment (mixers, blenders, mills, granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc.) Knowledge of instrumentation and techniques such as HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, SEM Ability to assimilate external data/research for new scientific projects and maintain broad knowledge of scientific principles Ability to lead multiple teams and exhibit leadership and project management skills Excellent computer and communication skills, problem-solving and analytical thinking Ability to meet multiple deadlines across projects with high accuracy and efficiency Excellent project management skills EEO/Disability/Vets employer. We are committed to a workplace of belonging, respect, and empowerment and encourage applicants from diverse backgrounds. The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on location, role complexity, and relevant experience. The position includes an annual bonus target of 30% of base salary and eligibility for equity-based long-term incentives. Benefits include retirement plan with company match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
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