Neurocrine Biosciences-posted 3 months ago
$108,600 - $157,350/Yr
1,001-5,000 employees

This position will serve as analytical SME to support Biologics (such as antibody, bioconjugates) CMC development. Develop, establish, and qualify/validate analytical methods used to monitor the critical product quality of drug substance and drug product. Contribute to the development and implementation of analytical development strategies and workflows. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of process intermediate, drug substance, drug product at all stages of development process.

  • Lead analytical method development and qualification/validation activities for the characterization of antibody and antibody conjugate utilizing various analytical techniques including but not limited to SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, Bioassays (ELISA, cell based assays), qPCR, LC-MS, NGS
  • Support cell line development to enable faster and informed decision making when needed.
  • Represent analytical development on CMC cross-functional teams and maintain accountability for analytical deliverables.
  • Support off-site analytical method transfers, manufacturing support, and interaction with external vendors when needed.
  • Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies.
  • BS/BA in Analytical Chemistry or related discipline and 5 years of experience in the analytical/pharmaceutical development field OR MS/MA in Analytical Chemistry or related discipline and 3 years of experience OR PhD in Analytical Chemistry or related discipline and some relevant experience; may include postdoc experience
  • Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development
  • Extensive experience and expertise with antibody modalities, focusing on analytical development
  • Proficient in characterization of antibody modalities using various analytical technologies including but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, molecular analysis (southern blot, northern blot, NGS, etc.)
  • Method development, qualification, validation, and transfer experience in Analytical Development
  • Comprehensive understanding of cGMP requirements in drug substance and drug product
  • Expert knowledge of cross-functional understanding related to drug development
  • Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
  • Excellent laboratory and productivity skills
  • Excellent interpersonal skills with strong oral and written communication abilities
  • Excellent problem solving and critical thinking skills
  • 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
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