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Sr. Scientist / Principal Scientist – Biologics Characterization

Sr. Scientist / Principal Scientist – Biologics Characterization

CompanyNeurocrine Biosciences
LocationSan Diego, CA, USA
Salary$128200 – $185900
TypeFull-Time
DegreesBachelor’s, Master’s, PhD
Experience LevelSenior, Expert or higher

Requirements

  • BA/BS in Biochemistry, Biology, or other relevant discipline and 8+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR Master’s/PhD in relevant discipline and 6+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques
  • PhD or equivalent and 4+ years of relevant experience; may include postdoc experience, Gene Therapy positions will require a PhD in Pharmacology, Neuroscience, Endocrinology, Physiology, or closely related discipline
  • BA/BS in Biochemistry, Biology, or other relevant discipline and 4+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR Master’s/PhD in relevant discipline and 3+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques
  • PhD or equivalent and some relevant experience; may include postdoc experience, Gene Therapy positions will require a PhD in Pharmacology, Neuroscience, Endocrinology, Physiology, or closely related discipline
  • Proficient in characterization of different biologic modalities using various modern technologies including but not limited to Analytical ultracentrifugation (AUC), Mass photometry, Size exclusion chromatography (SEC), Reverse phase chromatography, Ion exchange chromatography (IEX), Capillary gel electrophoresis (CGE), Mass spectrometry, Light scattering techniques (DLS, MALS) and Molecular analysis
  • Ability to independently plan and perform experiments for assay development, product release/stability/characterization, support for project activities with minimal supervision
  • Ability to interpret data, draw conclusions, and recommend next steps
  • Ability to identify and solve technical challenges
  • Ability to recommend alternatives as well as research new methods and techniques
  • Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)
  • Excellent interpersonal skills with strong oral and written communication abilities
  • Excellent laboratory and productivity skills

Responsibilities

  • Develop and optimize robust physicochemical and biophysical characterization methods for assessing product quality of AAV gene therapies and other biologics including Particle size analysis, AAV capsid distribution (various), Charge heterogeneity, Intact mass analysis, Post translational modifications, Thermodynamic analysis and other biophysical assays as applicable
  • Represent early-phase analytical development on cross-functional teams, communicates analytical strategy, planning, associated challenges to project teams
  • Maintain accountability for analytical deliverables and progress on lead optimization and manufacturing plans for all development projects
  • Apply advanced analytical techniques, methodologies for better understanding of the process and drug substance/drug product
  • Analyze experimental data, generating plots and summarizing results and conclusions
  • Maintain a comprehensive Electronic Lab Notebook documenting experiments
  • Maintain a high level of productivity in the team with clear daily, detailed, and accurate documentation of experiments
  • Work independently and collaborate with team members to meet project goals, and advance novel biologic candidates into pipeline
  • Author analytical method protocols, technical reports, transfer documents and supporting documents for regulatory filings
  • Support off-site analytical method transfers, manufacturing support, and interaction with CMC and external vendors
  • Build and enhance internal and external professional relationships

Preferred Qualifications

  • Prior industry experience preferred