Senior Scientist I

Role Summary

The Senior Scientist I will be an integral part of the Analytical Development team in the Operations – Product Development Science and Technology – Biologics division. The role involves managing all analytical aspects of biologics products at different stages of their drug development lifecycle with a focus on advancing AbbVie’s late-stage clinical programs. The individual will play a key role in analytical method development/transfer/validation/troubleshooting to support GMP release and stability studies, specification setting and justification, biologics DS process development, characterization, validation as well as GMP manufacturing investigation activities. Collaboration with other analytical teams, quality control, bioprocess development, and R&D groups is a crucial part of this role. Represent Analytical Development in CMC teams, communicate effectively with stakeholders, providing support for AbbVie late-stage assets to meet business objectives and program milestones.

Responsibilities

• Lead method development, troubleshooting and analytical testing efforts to support AbbVie pipeline programs using separation-based methods including HPLC (e.g. SEC, IEX, RPLC) and capillary electrophoresis (CE, icIEF), etc
• Demonstrate scientific excellence, advance science and innovation. Implement novel analytical techniques to enhance method robustness and expand analytical capabilities (including platform methods) across the life-cycle support of AbbVie early and late stage programs.
• Partner with other groups in the Analytical Development team to provide analytical support for pipeline programs, including but not limited to ELISA, bioassays, mass spectrometry, biophysical, spectrophotometric and compendial methods.
• Participate in cross-functional, multi-site meetings / projects and coordinate analytical activities that need to be supported in the Analytical Development team for pipeline programs.
• Participate in the preparation and review of internal technical documents to ensure compliance.
• Author regulatory submissions and provide scientifically sound responses to agency deficiency letters.
• Mentor or supervise junior members in the same team.

Qualifications

• Required: Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Required: Possess thorough theoretical and practical understanding of own scientific discipline.
• Preferred: PhD in chemistry, biochemistry, biological sciences, chemical engineering or related scientific disciplines with 0-2 year relevant experience.
• Preferred: Experience in analytical method development, validation, and transfer in support of biological products is preferred. Methods including but not limited to HPLC/UPLC, capillary electrophoresis, spectrophotometry, mass spectrometry, biophysical methods, ELISA and bioassays.
• Preferred: Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Preferred: Ability to lead and manage projects of significant scope and complexity, while meeting all deliverables and timelines.
• Preferred: Ability to effectively communicate with stakeholders and collaborate with cross-team partners.