Senior Scientist, II

Role Summary

Senior Scientist II responsible for analytical chemistry supporting commercial and pipeline small molecule development within the Science and Technology, Pharmaceutical Product Group. The role emphasizes leading analytical development for drug substance and drug product, with LC-MS expertise, method development, impurity analysis, and regulatory documentation. Collaboration across CMC development and AbbVie functions is required to advance drug development.

Responsibilities

• Lead analytical development, especially in peptide and protein LC-MS, to support drug substance and drug product development and manufacturing, including compound structural elucidation, impurity separation, isolation and structural identification, and control strategy development.
• Participate in analytical team activities. Mentor other team members for technical capability development. Provide project proposals and reviews, resource estimation and tracking, and periodical updates to management.
• Independently design experiments, review data and complete results interpretation and reporting. Prepare and review documents for regulatory submissions.
• Lead the analytical aspects of a project while collaborating with other CMC development functions and other areas in AbbVie to advance drug development.
• Responsible for method development, testing procedures, and implementation of analytical controls to support late-stage analytical development.
• Applying analytical separation and detection modes, such as LC-MS, GC-MS etc, for complex impurity identification/quantitation or low level quantitation.
• Support commercial manufacturing by participating as an analytical expert in investigations, troubleshoot analytical method issues, and improve method execution.
• Implement a wide range of current analytical techniques to conduct research and development studies related to drug product development.
• Introduce new technologies to analytical chemistry labs, including advancements in separation technology, mass spectrometry techniques, data science, and data trending.
• Perform routine and non-routine testing of development, release, and stability samples.

Qualifications

• Required: BS or equivalent education and extensive, typically 12+ years of experience; MS or equivalent education with typical 10+ years of experience; PhD with typical 0-4 years of experience in Chemistry or related fields in a pharmaceutical development laboratory setting.
• Preferred: Advanced degree is preferred.
• Required: Strong background in mass spectrometry and applications in pharmaceutical development is required.
• Required: Strong competency in mass spectrometry data interpretation and structural characterization using MS and tandem MS techniques.
• Required: Experience in developing quantitative analytical methods using mass spectrometry.
• Required: Proficiency with state-of-the-art high-resolution LC-MS instrumentation (e.g., Orbitrap and Q-Tof).
• Required: Proficiency with analytical techniques, e.g., HPLC, GC, spectroscopic techniques, and physicochemical characterization techniques.
• Required: Candidate must possess solid fundamental training in separation theory.
• Required: Candidate must possess outstanding oral and written communication skills.
• Required: Familiar with ICH and FDA guidance documents in analytical, DS and DP development and manufacturing.
• Required: This position requires an individual who is self-motivated, hard-working, detail-oriented, and able to work in a fast-paced team environment with demonstrated problem solving skills.
• Required: Proven track record in leading analytical projects within a CMC development team setting.

Skills

• Builds strong relationships with peers and cross functionally with partners outside of team 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.

Education

• BS or equivalent in Chemistry or related field.
• MS or equivalent in Chemistry or related field (preferred).
• PhD in Chemistry or related field (typical 0-4 years of experience).