Sr. Scientist / Principal Scientist, Product Development - Early 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:

Seeking a highly motivated and experienced scientist to join our CMC-Product Development, Early Stage team. The successful candidate will be responsible for designing and executing experiments to characterize and develop novel peptide and protein-based therapeutics that are advancing toward the clinical development phase. Additionally, this candidate will assess outcomes related to product characteristics, performance (including stability) and quality by deploying appropriate methodology to generate in-vitro data that informs the overall developability risk profile and guides next steps in drug product design and development.

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

• Design and execute developability assessments of novel peptides/protein-based therapeutics (and salt forms thereof) to inform selection of development compounds with drug-like properties

• Design, develop,  characterize and optimize various drug product formulations in support of preclinical and early stage clinical studies

• Develop phase appropriate analytical methods to support evaluation of physiochemical properties and stability of prototype peptide/protein formulations (e.g., HPLC-based assay/purity methods, SEC-MALS, DLS, isoelectric point, etc.)

• Investigate and implement new technologies utilized to characterize peptide/protein-based therapeutics to expand capabilities and platforms within the Product Development department

• Actively collaborate and share expertise with R&D partners

• Effectively communicate scientific rationale, results and interpretations at project, group and department-level meetings

• Maintain meticulous and up-to-date laboratory records and generate study reports (e.g, summary of developability studies, formulation development summaries, etc.)

• Support other activities of drug product development programs as needed

Requirements:

• BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 12+ years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory setting. Experience with the following instrumentation and techniques is required; HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM. Experience managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAs OR

• MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 10+ years of similar experience noted above OR

• PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above; may include postdoc experience

• Working knowledge in the following instrument/testing: HPLC-UV, LC-MS, SEC-MALS, viscosity, osmolality, dynamic light scattering (DLS), capillary isoelectric focusing (cIEF), subvisible particulate matter, density, injectability, etc.

• Experience with antibody and peptide development is a plus

• Technical writing: protocols, SOPs, and reports

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

• Proficient in all formulation-enabling aspects of characterization for peptide and other protein-based therapeutics

• Experience in peptide chemistry and knowledge of structural predictive degradation pathways is a is a positive differentiator for this role

• Excellent interpersonal skills with strong oral and written communication abilities

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

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

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

• Excellent computer skills, communications, problem-solving, analytical thinking skills

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

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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 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.