Job opening

Scientist

BioTalent

Tustin, CA

Filed under Staffing and Recruiting

Full job description

🚨 Hiring: Scientist, Analytical Development | Biologics / Large Molecules

We’re looking for an experienced Scientist, Analytical Development to support the development, characterization, validation, and transfer of analytical methods for large-molecule / protein biologic products.

⚠️ LARGE-MOLECULE / BIOLOGICS EXPERIENCE IS REQUIRED.

Candidates whose experience is primarily in small molecules without hands-on biologics/protein experience will not be a fit for this position.

What we’re looking for:

  • BS in Biochemistry, Chemistry, Biology, or related scientific discipline
  • 8+ years of biotech industry experience in Analytical Development, QC, or a related analytical laboratory environment
  • Demonstrated large-molecule / protein biologics analytical experience
  • Hands-on experience with HPLC, CE and/or Potency/ELISA
  • Experience with protein characterization, chromatography, electrophoresis, and assay validation/qualification
  • Experience developing, troubleshooting, validating, and transferring analytical methods
  • Strong understanding of GMP/cGMP environments and regulatory expectations
  • Ability to review analytical data, investigate issues, prepare technical documentation, and provide scientific leadership
  • Experience collaborating cross-functionally with QC, Manufacturing, Process Development, Project Management, and/or external clients

Key responsibilities include developing and troubleshooting analytical methods, leading method development and validation activities, supporting stability and process-development studies, serving as an analytical SME, authoring/reviewing methods and SOPs, and transferring methods into QC.

đź’° Competitive compensation , depending on experience and qualifications, plus bonus and benefits.

  1. Important: Please highlight your direct experience working with large-molecule biologics/proteins, including the specific analytical techniques you have used, when applying.


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