Sr. Scientist, Bioanalytical (PK/ADA)

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:

The Bioanalytical Senior Scientist, as part of the preclinical team, will develop and perform immunoassays to quantify large molecule therapeutics in biological fluids and tissues with a focus on pharmacokinetics (PK) and immunogenicity (ADA) assessments. The qualified individual will be responsible for the implementation of various types of assay platforms (e.g., ELISA, electrochemiluminescence) to answer key questions related to pharmacokinetics, pharmacodynamics, and immunogenicity in a regulated setting. This role is ideal for a candidate with a strong foundation in regulated bioanalytical analysis of biologics, with experience in PK and ADA methodologies, and data interpretation to support the preclinical development of therapeutics.

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

• Develop custom reagents and assays on various platforms (e.g., ELISA, electrochemiluminescence, Gyros) for pharmacokinetic and/or immunogenicity assessments

• Perform sample analysis to support bioanalysis efforts for non-regulated and regulated preclinical studies, including pharmacokinetics, pharmacodynamics, immunogenicity, and biological activity

• Lead the development and qualification of ADA assays (e.g. bridging electrochemiluminescence) to assess immunogenicity in biologic programs

• Work collaboratively with internal stakeholders to support CRO selection and oversee the transfer of internal assays to support regulated preclinical studies

• Lead troubleshooting efforts for both bioanalytical internal methods as well as methods at CROs to ensure data quality

• Effectively communicate results to internal/external teams in presentations and internally authored reports

• Prepare documents to support technical transfer of methods to CROs

• Manage and maintain a safe, organized, and operational laboratory space including maintenance of equipment and procurement of supplies

• May QC study reports and regulatory submissions

• Performs other duties as assigned

Requirements:

• BS/BA degree in Biology or closely related field and 5+ years of industry experience in an biotech, pharma, and/or CRO setting; Experience working in and accomplishing tasks a timeline driven setting; Experience in large molecules or biomarkers bioanalysis is preferred OR ​

• MS/MA degree in Biology or closely related field and 3+ years of similar experience noted above OR 

• PhD or equivalent and some industry experience; may include postdoc experience 

• Degree in biology, chemistry, or related science, preferably with experience in a bioanalytical laboratory

• Background in bioanalytical job-relevant core competency (immunoassays such as ELISA, handling of a variety of biological matrices such as serum and plasma, automation, method development/validation GLP studies, biomarker analysis)

• Hands-on experience with role-appropriate technology and methodology such as: automation, radioisotope use, PK analysis and modeling and simulation software

• Previous experience in cross-functional teams and in a scientific or clinical setting supporting drug development

• Developing strong written and verbal communication skills

• Knowledge of regulatory requirements for bioanalytical assays

• Experience with the generation of immunoassay critical reagents and reagent life cycle management

• Developing the ability to recognize anomalous and inconsistent results and interprets experimental outcomes

• Developing strong knowledge of scientific principles, methods and techniques

• Ability to work with a variety of laboratory instrumentation and/or PK analysis and or modeling and simulation software

• Excellent computer skills

• Developing problem-solving, analytical thinking skills

• Ability to meet multiple deadlines, 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 $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.