Job Description:

Who We Are:

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 patient suffering and enhance lives.

What We Do:

Neurocrine Biosciencesis a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered inSan Diego,Neurocrine Biosciencesspecializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

About the Role:

Develop, design and execute formulation and process related studies to support development projects from Phase I through commercial. Manage, with a formulation slant, full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, scale-up and optimization, packaging, packaging and stability testing of drug products. Establish CRO/CMO relationships to support clinical programs. Oversee process development and successful technical transfer for Neurocrine drug products to CDMOs. Represent CMC 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.

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Your Contributions (include, but not limited to):

• Develop and optimize phase-appropriate formulations (and processes) to meet target product profile and project needs




• Lead weekly or bi-weekly NBI-CMO project team meetings and inform both up and down the chain of command as to progress, resource gaps and timelines




• Participate and/or lead investigations as a SME where applicable on atypical or aberrant results on projects ranging from preformulation through to commercial




• Identify, evaluate, and ensure outsourcing partners have the required expertise, capabilities, and quality/compliance standards to support drug product formulation development, method development, manufacturing and packaging




• Research new instrumentation, equipment, and formulation technologies to be implemented when needed for development of target formulations




• Present updates at department meetings and deliver scientific talks on current and new techniques/technology in support of formulation and process development




• Collaborate effectively with Product Development Early Stage, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain colleagues and external/CDMO partners to efficiently advance projects from Phase IIb through commercial launch




• Oversee purchase, installation and maintenance R&D laboratory equipment and instrumentation as lead user, and train/mentor others in the department on use




• Author development reports, protocols, memos, specifications, and other relevant documentation and enter it into the preformulation information repository to allow for efficient access and retrieval by others




• Review CMC regulatory documents, batch records, specifications, development protocols, and product development reports ensuring scientific integrity and compliance with all regulatory requirements




• Represent Product Development as "person-in-plant" during manufacturing campaigns and onsite meetings, acting as an exemplary ambassador of NBI




• Other duties as assigned

Requirements:

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 12+ years of experience in the pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting. * Experience with solid dosage form development from preformulation through validation, 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. managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Extensive experience preparing INDs & NDAs OR




• Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 10+ years of similar experience noted above OR




• PharmD preferred and 4+ years of similar experience noted above




• Must have a thorough understanding of cGMPs relating to drug product manufacturing and regulatory guidelines and processes and a strong quality mindset




• Extensive 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




• Strong familiarity with analytical methods, validation, technology transfers and stability programs are needed




• Management experience in strategic planning, budgets, project management plus regulatory experience in preparing and authoring the drug product sections of INDs and NDAs




• Holds self accountable for mistakes of self and department and can set targets and articulate results.




• Must have a strong understanding of cGMPs relating to late drug product manufacturing.




• Expert 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.




• Knowledge of the following instrumentation and techniques is preferred; HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM




• Assimilates data and research findings outside of Neurocrine for application to new scientific projects




• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas




• May develop an understanding of other areas and related dependencies




• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools




• Ability to work as part of and lead multiple teams




• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams




• Excellent computer skills




• Excellent communications, problem-solving, analytical thinking skills




• Sees broader picture, impact on multiple programs, teams and/or departments




• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency




• Excellent project management skills

#LI-LS1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

As a condition of employment with Neurocrine Biosciences, Inc. in the United States, you must be fully vaccinated for COVID-19 and provide valid proof of vaccination to the company.

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