Purpose:
Technical expert who independently investigates, identifies, develops, and optimizes new methods/techniques for critical project needs, to support both laboratory and commercial manufacturing processes. Apply scientific/engineering principles and statistical process design/analysis to develop robust antibody manufacturing processes. Act as lead scientist, critically evaluate scientific/regulatory advances, and integrate into R&D programs. Support manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of ADCs. Requires in-depth knowledge of late-phase process transfer, process validation, process improvements. Strong cross-functional communication needed.
Major Responsibilities:
1. Resolve key project hurdles using technical expertise; support late-stage/commercial biologics manufacturing, tech transfer, process validation, investigations, troubleshooting, scale-up, continuous improvement
2. Work in dynamic/diverse team to support & troubleshoot current commercial manufacturing
3. Support/lead new product introduction at AbbVie sites or third-party manufacturers; ensure successful tech transfer, scale-up, validation
4. Support CMC life-cycle management and post-approval continued process validation for commercial antibody processes
5. Collaborate with process development on late-stage tech transfers, scale-up, and validation during transition to commercial manufacturing
6. Support product investigations/non-conformances; identify root causes; make scientific/quality recommendations
7. Author/review CMC sections of submissions; support agency inspections, inquiries, audits
8. Represent MSAT antibody group in CMC program teams; maintain strong internal/external relationships
9. Adhere to corporate standards (code of conduct, safety, GxP, controlled substances, animal care where applicable)
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