Scientist / 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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Supports Product Development within CMC project teams from Phase IIb through commercial launch, providing formulation development expertise for multiple clinical programs. Executes (may design) formulation studies to develop safe and therapeutically effective market image dosage forms. Work with lead scientist(s), optimize formulations in a phase-appropriate manner to achieve desired product attributes and performance per the TPP. Collaborates with internal cross-functional teams and CMOs to determine commercial manufacturing requirements. Experience in different molecular modalities, including small molecules, peptides, proteins, and long-acting injectables is preferred. Search, assess, and share/teach up-to-date scientific and technical knowledge and information on formulation approaches related to the company’s drug product development programs.

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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 Ib 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

Requirements:

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 6+ years of experience in the pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting. Experience with formulation development from preformulation through validation

• Master's degree in Pharmaceutics, Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 4+ years of similar experience noted above OR

• Ph. D. (preferred) in Pharmaceutics, Analytical Chemistry, Chemistry and 2+ years of similar experience noted above

• Experience with in vitro performance testing including dissolution and HPLC potency and impurity testing

• Experience in preparing CMC sections of INDs & NDAs preferred

• Thorough understanding of principles and design of various drug delivery systems/formulations (preferred experience in both peptides/proteins and small molecules)

• Extensive hands-on experience and knowledge of in vitro performance assessment of various formulations e.g., HPLC testing, dissolution studies, etc

• Good understanding of health authority regulations and guidelines for drug product development and approval processes

• Knowledge in statistics and statistical thinking in formulation and process design and validation

• Good knowledge of various drug product manufacturing processes

• Good understanding of drug development and commercialization processes

• Working knowledge in applying QbD principles in drug product development

• Technical writing: protocols, reports, SOPs, etc

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

We are committed to building a diverse, equitable, and inclusive workplace, 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 $86,200.00-$125,050.00. 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.