Principal Scientist, Product Development Late Stage

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 suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X and Facebook . ( *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 an enabled 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 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.
Key areas of focus include: solubility enhancement, modified release dosage forms, amorphous solid dispersions (Spray Drying and Hot Melt Extrusion), self-emulsifying drug delivery systems (SEDDS), low dose/drug load product design, dry granulation, tableting, and encapsulation.

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Your Contributions (include, but are 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 and process 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 of DP Pilot Plant 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 to allow for efficient access and retrieval by others

• Review and author 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 8+ years of experience in the pharmaceutical industry in a late-phase product development 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 Contract Manufacturing Organizations. Extensive experience preparing INDs & NDAs OR

• Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 6+ years of similar experience noted above OR

• PhD in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field 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

• Ability to analyze data sets from formulation and process development, identify trends and make data driven decidions to optimize outcomes

• Advanced level knowledge of ICH, FDA, EMA guidance in CMC and Quality Areas

• 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 solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, twin screw extruders, spray driers, encapsulators, tablet presses, film coaters, etc.

• 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 (Excel, Word, Outlook, OneNote, JMP, etc)

• 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

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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 dont line up to exactly what we have outlined in the job description.

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The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. 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 30% 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.