About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
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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
- ✓Resolve key project hurdles using technical expertise; support late-stage/commercial biologics manufacturing, tech transfer, process validation, investigations, troubleshooting, scale-up, continuous improvement
- ✓Work in dynamic/diverse team to support & troubleshoot current commercial manufacturing
- ✓Support/lead new product introduction at AbbVie sites or third-party manufacturers; ensure successful tech transfer, scale-up, validation
- ✓Support CMC life-cycle management and post-approval continued process validation for commercial antibody processes
- ✓Collaborate with process development on late-stage tech transfers, scale-up, and validation during transition to commercial manufacturing
- ✓Support product investigations/non-conformances; identify root causes; make scientific/quality recommendations
- ✓Author/review CMC sections of submissions; support agency inspections, inquiries, audits
- ✓Represent MSAT antibody group in CMC program teams; maintain strong internal/external relationships
- ✓Adhere to corporate standards (code of conduct, safety, GxP, controlled substances, animal care where applicable)
- ✓B.Sc. + 7+ years, OR M.Sc. + 5+ years relevant experience
- ✓Field: Biology, Biochemistry, Chemical or Biochemical Engineering, or related fields
- ✓Effective writer/communicator of research or regulatory materials
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html