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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Senior Scientist I, Analytical Chemistry - ARD

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Research & Development
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1906599 Requisition #
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The analytical development group for new biological entities (NBEs) develops antibody drug conjugates (ADC) and other biologics by state of the art analytical technologies. We prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

 

We are looking for a highly motivated person who can lead the analytical development of new biologic candidates from FIH through registration. The candidate will be responsible executing activities required for analytical development.  The candidate must be able to mentor junior staff with novel experimental approaches to answer scientific questions to develop and optimize NBE drug product formulations. Working closely with formulation and process development scientists, the Senior Scientist I will develop productive collaborations and communications with scientific teams.

 

Section I: Major Responsibilities

  • Design, execute and assess experimental data for analytical characterization, formulation/process development samples and clinical trial supplies (e.g. GMP compliant stability and batch release testing).

  • Support development of therapeutic proteins at various stages

  • Author and/or review key regulatory documents, laboratory data, technical memos and reports.

  • Support activities associated with formulation/process development design and characterization for new biologic compounds.
  • Mentor small project team(s) in the execution and design experiments for method development and validation studies.

  • Mentor junior staff in troubleshooting of equipment and experimental problems.

  • Encourage ideas for continuous improvement activities and initiatives within work group.

  • Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

 

 

 

 

  • BS with 10+ years experience; MS with 8+ years; or PhD (0 + years) in Chemistry, Biochemistry, Pharmacy or Biology required.  Previous work experience in a cGMP (i.e. QC or equivalent) pharmaceutical laboratory setting preferred.

  • Previous supervisory experience of laboratory staff (2+ years).

  • Experience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS).

  • Experienced in laboratory systems (LIMS, CDS, ELN) preferred.

  • Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

Key AbbVie Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of teams to enable higher performance.
  • Learns fast, grasps the "essence" and can change course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

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