Sr. Scientist, Prod Dev – Late Stg

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:

Represent Product Development within CMC project teams from Phase IIb through commercial launch, providing formulation development expertise for multiple clinical programs. Design and execute formulation studies to develop safe and therapeutically effective market image dosage forms.

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Your Contributions (include, but are not limited to):

• Collaborate 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
• Facilitate communications between departments and external partners, ensuring information is shared appropriately and effectively
• Demonstrate knowledge and Application of first principles of formulation and process science to develop quality dosage forms that meet phase-appropriate product profiles
• Execute excipient compatibility studies and prepare prototype formulations at bench scale
• Following QbD principles, plan and execute DOEs to optimize formulations that fit the product profile
• Operate pilot-scale pharmaceutical manufacturing equipment and characterization instrumentation to produce gram- to kilo-scale R&D batches of drug product
• Demonstrate knowledge and experience with multiple manufacturing technologies and apply appropriate technologies to the challenges presented by the molecule and product profile
• Maintain per SOP, a clear, legible laboratory notebook that accurately documents experiments conducted and results obtained
• Represent NBI as “person-in-plant” during on-site meetings and manufacturing campaigns at CDMOs, respecting the partner’s SOPs and communicating effectively
• Research new instrumentation and formulation technologies to be implemented when needed for drug product development
• Prepare and review pharmaceutical development reports, protocols, memos, specifications, and other relevant documentation, ensuring scientific integrity and compliance with all regulatory requirements
• Contribute to CMC regulatory dossiers as primary author and reviewer, as required
• Present updates at department meetings and deliver scientific talks on current and new techniques/technology in support of drug product development
• Source, procure, install, qualify, operate, and maintain instrumentation and equipment required for formulation and process development, as needed
• Lead or participate in periodic project team meetings and inform both up and down the chain of command as to progress, resource gaps and timelines

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
• PharmD preferred and some similar experience noted above OR
• 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 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 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 one or more scientific disciplines, becoming expert in one discipline
• 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; may train lower levels
• 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
• Strong project management skills
• 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
• Understands how to effectively negotiate, persuade, and influence

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.

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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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