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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