Director, Synthetic Molecules Analytical R&D
AbbVie
3 months ago
On-site
North Chicago, IL
Clinical Research and Development
Responsibilities:
- Lead development and implementation of advanced analytical characterization for drug substance and drug product methods to support modalities including small synthetic molecules and complex peptide programs.
- Use structure elucidation techniques (e.g., high-resolution tandem mass spectrometry, nuclear magnetic resonance) to characterize a wide range of modalities.
- Lead cross-functional teams and collaborate with multi-disciplinary experts to develop strategies for structure elucidation and impurity management, including control strategies for mutagenic and nitrosamine impurities.
- Advance scientific expertise by advising senior stakeholders, mentoring and training colleagues, and assessing emerging business challenges.
- Ensure quality and effectiveness of major project plan results through sound design, early risk assessments, and fallback strategies.
- Identify and integrate emerging scientific trends in molecular characterization of therapeutics into functional objectives and technology direction.
- Create and implement new or improved approaches, alternatives, and breakthrough ideas across disciplines.
- Contribute to project teams and drive programs through critical milestones across scientific disciplines.
- Generate and lead new scientific proposals; anticipate and respond to scientific or regulatory advances with updated strategies.
- Drive innovation and technical excellence; execute with scientific rigor to support overall CMC and portfolio strategy.
Qualifications:
- PhD (12+ years’ experience) in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, Chemical Biology or related) with prior pharmaceutical laboratory experience.
- Deep understanding of pharmaceutical development applications using mass spectrometry, NMR, impurity management and control strategy development, physical characterization (DSC, TGA, XRPD, FTIR, Raman, particle size/morphology analysis, microscopy), and biophysical techniques (e.g., optical spectroscopy; structure and binding).
- Practical experience with LC separations (HPLC, GC, IP-RP LC, SEC), capillary electrophoresis, and other separation techniques for small molecules and peptide/oligonucleotide analysis.
- Experience with project and people leadership in pharmaceutical development.
- Strong technical background with proven innovation (e.g., new/improved product release and publications).
- High-quality written and oral communication skills; ability to interact effectively with interdisciplinary scientists and engineers.
Benefits (if eligible):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k)
- Eligible to participate in short-term incentive programs
- Lead development and implementation of advanced analytical characterization for drug substance and drug product methods to support modalities including small synthetic molecules and complex peptide programs.
- Use structure elucidation techniques (e.g., high-resolution tandem mass spectrometry, nuclear magnetic resonance) to characterize a wide range of modalities.
- Lead cross-functional teams and collaborate with multi-disciplinary experts to develop strategies for structure elucidation and impurity management, including control strategies for mutagenic and nitrosamine impurities.
- Advance scientific expertise by advising senior stakeholders, mentoring and training colleagues, and assessing emerging business challenges.
- Ensure quality and effectiveness of major project plan results through sound design, early risk assessments, and fallback strategies.
- Identify and integrate emerging scientific trends in molecular characterization of therapeutics into functional objectives and technology direction.
- Create and implement new or improved approaches, alternatives, and breakthrough ideas across disciplines.
- Contribute to project teams and drive programs through critical milestones across scientific disciplines.
- Generate and lead new scientific proposals; anticipate and respond to scientific or regulatory advances with updated strategies.
- Drive innovation and technical excellence; execute with scientific rigor to support overall CMC and portfolio strategy.
Qualifications:
- PhD (12+ years’ experience) in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, Chemical Biology or related) with prior pharmaceutical laboratory experience.
- Deep understanding of pharmaceutical development applications using mass spectrometry, NMR, impurity management and control strategy development, physical characterization (DSC, TGA, XRPD, FTIR, Raman, particle size/morphology analysis, microscopy), and biophysical techniques (e.g., optical spectroscopy; structure and binding).
- Practical experience with LC separations (HPLC, GC, IP-RP LC, SEC), capillary electrophoresis, and other separation techniques for small molecules and peptide/oligonucleotide analysis.
- Experience with project and people leadership in pharmaceutical development.
- Strong technical background with proven innovation (e.g., new/improved product release and publications).
- High-quality written and oral communication skills; ability to interact effectively with interdisciplinary scientists and engineers.
Benefits (if eligible):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k)
- Eligible to participate in short-term incentive programs