Neurocrine Biosciences
Sr. Scientist, Product Dev - Late Stage
Neurocrine Biosciences, San Diego, California, United States, 92189
Overview
Who We Are: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a strong, inclusive culture and a shared purpose to relieve suffering for people with great needs. What We Do: We develop life-changing treatments for under-addressed neurological, neuroendocrine and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease-related chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with a robust pipeline in mid- to late-phase clinical development. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. (*in collaboration with AbbVie) About the Role:
Participate in developing and executing formulation and process design & engineering to support development projects from Phase I through commercial. Partner with a Quality by Design (QbD) mindset in 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. Ensure product quality, scalability and regulatory compliance. Develop CDMO relationships to support clinical programs. Assist with successful technical transfer for Neurocrine drug products to CDMOs. Participate within project teams to deliver high-quality, phase-appropriate drug products that address molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile. Your Contributions (include, but are not limited to):
Formulation Design and Optimization: Partner in designing and developing robust formulations for solid oral dosage forms (e.g., tablets, capsules), focusing on optimizing for stability, bioavailability, and manufacturability performance.
Process Development: Partner in developing and optimizing manufacturing processes, including powder mixing, blending, granulation, compression, and encapsulation, to help define critical quality attributes (CQAs) and critical process parameters (CPPs).
Scale-Up Support: Partner in formulation and process scale-up efforts from lab scale to pivotal and commercial scales, assisting with seamless technology transfer to CMO partner sites.
Project Team Participation: Participate in weekly or bi-weekly NBI-CMO project team meetings and provide Pharm Dev-specific updates on progress.
Regulatory Documentation: Contribute to authoring and reviewing sections of drug product documentation to support regulatory submissions.
Deviation Investigation: Support investigations as a subject matter expert (SME) on atypical or aberrant results for projects ranging from pre-formulation through commercialization.
Outsourcing Support: Assist in evaluating outsourcing partners and ensuring they have the required expertise, capabilities, and quality/compliance standards for drug product formulation development and manufacturing.
Commercial Product Support: Support Continuous Process Improvement (CPI) and Continuous Process Verification (CPV) for commercial products as needed, including troubleshooting technical challenges.
Technology Research: Research new instrumentation, equipment, and formulation/process technologies to be implemented for development of target formulations.
Departmental Collaboration: Support and participate in presentations at department meetings on current and new techniques/technology in support of formulation and process development.
Cross-Functional Collaboration: Collaborate effectively with internal Product Development, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain colleagues, as well as external CDMO partners.
Equipment Maintenance: Participate in the purchase, installation, and maintenance of DP Pilot Plant laboratory equipment and instrumentation.
Report Writing: Author development reports, protocols, memos, specifications, and other relevant documentation to allow for efficient access and retrieval by others.
Quality and Compliance Review: Review CMC regulatory documents, batch records, and development protocols to ensure scientific integrity and compliance. On-Site Representation: Represent Product Development as "person-in-plant" during manufacturing campaigns and onsite meetings.
Other duties as assigned
Requirements BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field AND 5+ years of pharmaceutical industry experience in a pharmaceutical product development laboratory setting; experience in solid dosage form development, and preferably with solubility enhancement, modified release, and/or pediatric dosage forms. Experience with conventional solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc. OR
Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred AND 3+ year of similar experience noted above OR
Ph.D. AND some similar experience noted above
Must have solid understanding of cGMPs relating to drug product manufacturing, and a strong quality mindset
Hands-on experience with solid dosage form manufacturing processes
Demonstration of cross-functional understanding related to drug development
Must have technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules
Familiarity with analytical methods, validation, technology transfers and stability programs
Holds self accountable for mistakes of self and department and can set targets and articulate results
Must have a good understanding of cGMPs relating to late drug product manufacturing
Strong knowledge of conventional solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc.
Demonstrates solid level of understanding project / group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Able to explain the process behind the data and implications of the results
Strong knowledge of scientific principles, methods and techniques
Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Ability to work as part of a team
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture of scientific impact on team
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Effective report writing and oral presentations skills are required
Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
Ability to creatively solve complex problems in a team environment
#LI-DM1 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 $108,600.00-$157,350.00. 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.
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Who We Are: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a strong, inclusive culture and a shared purpose to relieve suffering for people with great needs. What We Do: We develop life-changing treatments for under-addressed neurological, neuroendocrine and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease-related chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with a robust pipeline in mid- to late-phase clinical development. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. (*in collaboration with AbbVie) About the Role:
Participate in developing and executing formulation and process design & engineering to support development projects from Phase I through commercial. Partner with a Quality by Design (QbD) mindset in 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. Ensure product quality, scalability and regulatory compliance. Develop CDMO relationships to support clinical programs. Assist with successful technical transfer for Neurocrine drug products to CDMOs. Participate within project teams to deliver high-quality, phase-appropriate drug products that address molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile. Your Contributions (include, but are not limited to):
Formulation Design and Optimization: Partner in designing and developing robust formulations for solid oral dosage forms (e.g., tablets, capsules), focusing on optimizing for stability, bioavailability, and manufacturability performance.
Process Development: Partner in developing and optimizing manufacturing processes, including powder mixing, blending, granulation, compression, and encapsulation, to help define critical quality attributes (CQAs) and critical process parameters (CPPs).
Scale-Up Support: Partner in formulation and process scale-up efforts from lab scale to pivotal and commercial scales, assisting with seamless technology transfer to CMO partner sites.
Project Team Participation: Participate in weekly or bi-weekly NBI-CMO project team meetings and provide Pharm Dev-specific updates on progress.
Regulatory Documentation: Contribute to authoring and reviewing sections of drug product documentation to support regulatory submissions.
Deviation Investigation: Support investigations as a subject matter expert (SME) on atypical or aberrant results for projects ranging from pre-formulation through commercialization.
Outsourcing Support: Assist in evaluating outsourcing partners and ensuring they have the required expertise, capabilities, and quality/compliance standards for drug product formulation development and manufacturing.
Commercial Product Support: Support Continuous Process Improvement (CPI) and Continuous Process Verification (CPV) for commercial products as needed, including troubleshooting technical challenges.
Technology Research: Research new instrumentation, equipment, and formulation/process technologies to be implemented for development of target formulations.
Departmental Collaboration: Support and participate in presentations at department meetings on current and new techniques/technology in support of formulation and process development.
Cross-Functional Collaboration: Collaborate effectively with internal Product Development, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain colleagues, as well as external CDMO partners.
Equipment Maintenance: Participate in the purchase, installation, and maintenance of DP Pilot Plant laboratory equipment and instrumentation.
Report Writing: Author development reports, protocols, memos, specifications, and other relevant documentation to allow for efficient access and retrieval by others.
Quality and Compliance Review: Review CMC regulatory documents, batch records, and development protocols to ensure scientific integrity and compliance. On-Site Representation: Represent Product Development as "person-in-plant" during manufacturing campaigns and onsite meetings.
Other duties as assigned
Requirements BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field AND 5+ years of pharmaceutical industry experience in a pharmaceutical product development laboratory setting; experience in solid dosage form development, and preferably with solubility enhancement, modified release, and/or pediatric dosage forms. Experience with conventional solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc. OR
Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred AND 3+ year of similar experience noted above OR
Ph.D. AND some similar experience noted above
Must have solid understanding of cGMPs relating to drug product manufacturing, and a strong quality mindset
Hands-on experience with solid dosage form manufacturing processes
Demonstration of cross-functional understanding related to drug development
Must have technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules
Familiarity with analytical methods, validation, technology transfers and stability programs
Holds self accountable for mistakes of self and department and can set targets and articulate results
Must have a good understanding of cGMPs relating to late drug product manufacturing
Strong knowledge of conventional solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc.
Demonstrates solid level of understanding project / group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Able to explain the process behind the data and implications of the results
Strong knowledge of scientific principles, methods and techniques
Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Ability to work as part of a team
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture of scientific impact on team
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Effective report writing and oral presentations skills are required
Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
Ability to creatively solve complex problems in a team environment
#LI-DM1 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 $108,600.00-$157,350.00. 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.
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