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Principal Engineer, Biologics Drug Substance Technology Transfer
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Full-time
- This position will provide strong scientific leadership, mentorship and subject matter expertise for all aspects of drug substance including technology transfer, process fit analysis, process modelling, raw material controls and aseptic process assurance/microbiological control.
- The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Manufacturing sites.
- This includes continuous communication with Quality Assurance, Quality Control, Upstream and Downstream Process Development, Drug Product Development, Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's clinical drug substance manufacturing activities.
- Lead creation and/or technical review of batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion operations as applicable
- Serve as Drug Substance Team Lead, including representation at CMC asset team, to support late-stage pipeline programs through validation campaigns and initial commercialization, as required
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