Sr. Scientist / Principal Scientist - Product Development, Peptide Formulations

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:

Design and develop (hands-on in-house and through management of CDMO partners) phase-appropriate drug product formulations, processes, analytical methods and delivery systems for peptide and protein-based molecules for parenteral delivery in preclinical and clinical studies. Assess outcomes related to product characteristics, performance (including stability) and quality by deploying appropriate methodology to generate in vitro data that informs the overall risk profile and guides next steps in drug product design and development. Small molecule formulation and process development experience/expertise is a positive differentiator for this role. Share technical experience/expertise in the areas of peptide and protein formulation and process development with R&D colleagues by leveraging cross-functional “open lab” settings to demonstrate and teach the techniques and platforms that enable effective drug product development. Leverage and stay current on industry best practices and emerging technologies to the benefit of the company’s drug product development programs, including development acceleration strategies. Support various drug product development programs as needed.

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

• Design formulations/processes for parenteral delivery of peptides/proteins to support preclinical and clinical studies (small molecule parenteral and oral drug product development experience is a positive differentiator)

• Develop analytical methods for evaluation of various parenteral peptide/protein formulations (e.g, HPLC stability testing methods including SEC, RP, IEC.  Physicochemical characterization techniques including DLS, cIEF, circular dichroism, etc.)

• Understanding of compendial methods of sterile drug product manufacturing (e.g, sterility, endotoxin, sub-visible particles, pH, osmolality, etc.)

• Identify and manage CDMOs to assist with out-sourcing of manufacturing (compounding, sterile fill finish, etc) and release testing to support clinical studies

• Perform person-in-plant support (business travel) at CDMO partner facilities in support of clinical trial manufacturing, as needed

• Provide injectable formulation and peptide development training for other personnel to promote education of existing small molecule staff

• Lead development of 1 or more of Neurocrine’s clinical assets.

• Perform feasibility studies of various formulations for company’s drug candidates and support lead formulation selection

• Prepare study reports (e.g, summary of feasibility studies, formulation and process development, etc)

• Search and assess up-to-date scientific knowledge/information of various formulation approaches and maintain knowledge base of company’s interests

• Support other activities of drug product development programs when needed

Requirements:

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of experience in the pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting OR

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

• PhD (preferred) and  4+ years of similar experience noted above

• Managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAs

• Thorough understanding principles and design of various peptide/protein formulations (small molecule parenteral and oral drug product development experience is a positive differentiator).

• Formal understanding of ICH guidelines

• 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 in various drug product manufacturing processes

• Good understanding of drug development and commercialization processes

• Working knowledge in the following instrument/testing: HPLC (SEC-MALS), Particle-Size Analysis, viscosity, dynamic light scattering (DLS), Capillary Isoelectric Focusing (cIEF), Subvisible particulate matter, density, osmolality

• Working knowledge in applying QbD principles in drug product development

• Technical writing: protocols, SOPs, and reports

• Experience working at or with Contract Development and Manufacturing Organizations (CDMOs)

• 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 dependences

• 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-OB1

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 $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.