Sr. Scientist, Bioanalytical

Neurocrine Biosciences

112d • $108,600 - $157,350

About The Position

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.

Requirements

• BS/BA degree in Biology or closely related field and 5+ years of industry experience in a biotech, pharma, and/or CRO setting
• Experience working in and accomplishing tasks in 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
• 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

Responsibilities

• 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

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees