3h ago

Senior Engineer, ADC Manufacturing

Syracuse, NY
full-timeseniorbiopharmaceutical

Tech Stack

Description

As a Senior Engineer in ADC Manufacturing at LOTTE BIOLOGICS, you will serve as a technical SME for antibody drug conjugate processes, driving process robustness, investigating deviations, and implementing improvements to ensure cGMP compliance.

Requirements

  • Bachelor’s in Chemical Engineering, Chemistry, Biology or related field (MS/PhD preferred)
  • 7+ years in biopharmaceutical MSAT, Process Engineering, or Manufacturing Sciences
  • 2-4 years specifically in ADCs or complex bioconjugation processes strongly preferred
  • Hands-on cGMP clinical or commercial manufacturing experience
  • Technical understanding of conjugation chemistries, purification technologies, and HPAPI handling

Responsibilities

  • Serve as primary technical authority for ADC conjugation, formulation, and purification processes
  • Lead technical transfers for First in Human, scale up, late-stage, and validation activities
  • Own and improve key unit operations (TFF, chromatography, conjugation reactions, solvent handling, buffer preparation)
  • Lead investigations, root cause analysis, and CAPA development for OOS, OOT, and deviations
  • Author and review technology transfer documents, master batch records, SOPs, protocols, and reports
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