Senior
Scientist II, Global Technical Operations
Company Description
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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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:
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Resolve key project hurdles using technical expertise; support late-stage/commercial biologics manufacturing, tech transfer, process validation, investigations, troubleshooting, scale-up, continuous improvement
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Work in dynamic/diverse team to support & troubleshoot current commercial manufacturing
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Support/lead new product introduction at AbbVie sites or third-party manufacturers; ensure successful tech transfer, scale-up, validation
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Support CMC life-cycle management and post-approval continued process validation for commercial antibody processes
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Collaborate with process development on late-stage tech transfers, scale-up, and validation during transition to commercial manufacturing
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Support product investigations/non-conformances; identify root causes; make scientific/quality recommendations
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Author/review CMC sections of submissions; support agency inspections, inquiries, audits
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Represent MSAT antibody group in CMC program teams; maintain strong internal/external relationships
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Adhere to corporate standards (code of conduct, safety, GxP, controlled substances, animal care where applicable)
Qualifications
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B.Sc. + 7+ years, OR M.Sc. + 5+ years relevant experience
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Field: Biology, Biochemistry, Chemical or Biochemical Engineering, or related fields
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Demonstrated experience with biologics DS operations
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Knowledge of GMP
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Effective writer/communicator of research or regulatory materials
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Demonstrated ability to lead and influence cross-functional teams
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Strong analytical skills
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Travel up to 10%
Additional Information
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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