Sr. Scientist, Bioanalytical
- Neurocrine Continental Inc.
- US CA San Diego
- 8mo ago
- Full-Time
- On-site
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.
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 assays to quantify large molecule therapeutics in biological fluids and tissues using ligand binding assays (LBA). 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. This role is ideal for a candidate with a strong foundation in bioanalytical analysis of biologics, with demonstrated experience in fit for purpose method development supporting regulated and non-regulated programs._
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
Develop custom reagents and perform method development on various platforms (e.g., ELISA, electrochemiluminescence, Gyros) for pharmacokinetic and/or immunogenicity assessments
Perform sample analysis to support bioanalysis efforts for non-regulated preclinical studies, including pharmacokinetics, pharmacodynamics, immunogenicity, and biological activity
Execute bioanalytical sample analysis using automated liquid handling platforms (e.g., Tecan, Hamilton, Beckman Coulter, or equivalent)
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
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 similar experience as noted above or PostDoc work OR
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
Hands-on experience with automated liquid handling systems (Hamilton, Tecan, Bravo, or similar)
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
#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 $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.