Principal Research Scientist I (Analytical R&D for LNP and Small Molecule)

For the Principal Research Scientist I position, we are seeking a highly motivated, experienced analytical scientist to be an Analytical Project Leader in New Chemical Entities (NCEs) drug substance and drug product in both preclinical and clinical programs.  The candidate should have extensive expertise within an R&D environment with a fit for purpose mindset.  Expertise with synthetic molecules in solid oral dosage forms is expected. Additional experience with lipid nanoparticles highly desired. 

The qualified candidate should be able to conceive, execute and communicate novel strategies that achieve project goals and department imperatives across a multi-disciplinary research and development organization. They must have experience as an analytical project lead and demonstrate a capability to manage CMC deliverables relevant to early-phase clinical development and on discovery programs with pre-clinical candidate compounds.

The qualified candidate must foster productive collaborations within the global Analytical R&D organization and with R&D cross-functional partners such as Discovery, Pre-Clinical Safety, Process Chemistry, Process Engineering, Molecular Profiling and Drug Delivery, Drug Product Development, and Quality Assurance and CMC-Regulatory.

The qualified candidate will be based at the AbbVie Bioresearch Center in Worcester, MA. However, they must be able to provide 50% on-site support at the AbbVie Bioresearch Center in Worcester, MA and 50% on-site support at the AbbVie Cambridge Crossing site in Cambridge, MA according to project needs.

Responsibilities:

• Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to advise the selection of molecules with properties suitable for development.
• Generate new scientific proposals and lead those efforts. Anticipate and critically

            evaluate scientific or regulatory advances or competitive threats and respond with

            appropriate new strategies.

• Demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
• Raises the bar and is never satisfied with the status quo.
• Understand and comply with AbbVie safety, quality and regulatory policies and government regulations. 

 

• Bachelors, Masters, or Ph.D. in Analytical Chemistry typically with a minimum of 14 (BS), 12 (MS), or 6 (Ph.D.) years related industry experience.
• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshooting analytical methods.
• Demonstrated leadership with solving technical challenges across therapeutic modalities, specifically the lipid nanoparticle (LNP) and small molecule spaces.
• Demonstrated experience with a variety of mass spectrometry (MS) instrumentation and applications for structure elucidation and trace quantitation is highly desired.
• Fundamental understanding and working knowledge of various analytical techniques including HPLC, UPLC, GC, DSC, TGA, DVS, PXRD, NMR, dissolution.
• Familiarity with the role that physicochemical properties play in drug delivery and formulation design.
• Working knowledge of typical formulation approaches and routes of administration (i.e. IV, SC, IP, PO) across multiple species.
• Knowledge of preclinical and clinical formulation development principles relevant to lipid nanoparticle formulations.
• Demonstrate creative out-of-the-box thinking to solve difficult problems
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.