Director, Synthetic Molecules Analytical R&D

Role Summary

Director, Synthetic Molecules Analytical R&D leads a team focused on structural elucidation, impurity management (including nitrosamine and mutagenic impurities), and physical analytical characterization for stability modeling of synthetic molecules and peptides. You will design, develop, and implement technology for the characterization of drug substances and drug products across synthetic and peptide modalities, and support chemistry, manufacturing, and controls (CMC) activities with analytical methods throughout development. The role provides scientific leadership, strategic direction, and cross-functional collaboration to ensure robust analytical control strategies aligned with regulatory expectations; we value diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team.

Responsibilities

• Lead development and implementation of advanced analytical characterization for drug substance and drug product methods to support a range of modalities including small synthetic molecules and complex peptide development programs.
• Utilize cutting-edge structure elucidation techniques (e.g., high-resolution, tandem mass spectrometry, nuclear magnetic resonance) to characterize a wide range of modalities across AbbVie’s pipeline.
• Lead cross-functional teams and collaborate with multi-disciplinary experts to develop strategies to enable the structure elucidation aspects of a project to advance programs through the development pipeline including impurity management to develop control strategies for mutagenic and nitrosamine impurities.
• Advance scientific expertise beyond ARD organization. Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor and train colleagues and assesses current and emerging business challenges enabling functional goal achievement.
• Ensure quality and effectiveness of key results of major project plans through sound design, early risk assessments, and implementation of fallback strategies.
• Source and identify emerging scientific trends in the field of molecular characterization of therapeutics from internal and external sources and assess relevance. Integrate trends into functional short-term objectives. Advance cross discipline technology and direction within area of discipline.
• Apply imagination and innovation by creating, inventing, and implementing new or better approaches, alternatives and breakthrough ideas across disciplines.
• Make significant contributions to project team and deliver results in a team-oriented setting and will work across scientific disciplines to drive programs through critical milestones.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances and respond with appropriate new strategies.
• Drives innovation and technical excellence for a multi-functional organization.
• Drive scientific rigor, operational excellence, and consistent execution as a key contributor to overall CMC and portfolio strategy.

Qualifications

• PhD (with 12+ years’ experience) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, Chemical Biology or related field) with previous pharmaceutical laboratory experience.
• Deep understanding of pharmaceutical develop applications utilizing mass spectrometry, nuclear magnetic resonance spectroscopy, impurity management and control strategy development, physical analytical characterization (DSC, TGA, XRPD, FTIR, Raman, particle size and morphology analysis, microscopy), and biophysical techniques (e.g. optical spectroscopy, structure, and binding).
• Practical experience and strong knowledge of LC separations (e.g., HPLC, GC, IP-RP LC, SEC), capillary electrophoresis, and other separation techniques as applied to small molecules and peptide/oligonucleotide analysis.
• Experiences with the project and people leadership in the development of pharmaceutical development.
• Strong technical background with proven ability to innovate with a history of new or improved product release and publications.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.