Senior Scientist I/II, Analytical Chemistry- Predictive Stability, Mass Spectrometry

AbbVie Analytical Research & Development (Analytical R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.  Our scope includes AbbVie's diverse pipeline of innovative small molecule medicines and spans from the selection of Discovery candidate molecules to Late Stage Clinical.  We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.  Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.  We are looking for diverse candidates with strong scientific experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates. 

 

For the Senior Scientist II position, we are seeking a highly motivated candidate who can conceive, implement and execute novel scientific research and development. Generate new scientific proposals and lead these efforts. Act as a lead scientist in his/her area of expertise and critically evaluate relevant scientific and regulatory advances and integrate this knowledge into research and development programs. As part of the Predictive Stability and Structure Elucidation team, they will collaborate with analytical and cross-functional teams to build the understanding of stability attributes and degradation pathways for synthetic molecule APIs.

He/she should possess an understanding of core discipline and support early phase development of New Chemical Entities (NCEs) drug substance and drug product in both preclinical and clinical programs. Collaborate within the global Analytical R&D organization and with R&D cross-functional partners such as Pre-Clinical Safety (PCS), Process Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC-Regulatory.  

Responsibilities:

• Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to further the understanding of emerging cGMP manufacturing processes.
• Responsible for leading the predictive stability aspects of a project while working with other functional areas to advance projects through the development pipeline.
• Utilize understanding of a range of analytical techniques to conduct research and development studies related to small-molecule drug products, active pharmaceutical ingredients, intermediates, starting materials, impurities and impurity profiling.
• Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data in support regulatory requirements.
• Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Process, interpret, and visualize data to facilitate project team decisions.
• Communicate and collaborate with cross-functional groups and departments.
• Routinely demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
• Responsible for method development, testing procedures, and implementation of analytical control strategies to help the advancement of drug discovery candidates.
• Raises the bar and is never satisfied with the status quo.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.

• 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.
• Practical understanding of organic chemistry reactions as related to potential degradation mechanisms of small molecules and peptides
• Experience with structure elucidation for small molecules, particularly by high resolution mass spectrometry (Orbitrap, QTOF, etc).
• Experience developing LC-MS methods for trace quantitation is a plus.
• Some experience using computational tools to model chemical processes or reactions
• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshooting analytical methods.
• Hands on experience with HPLC analysis and method development along with expertise and fundamental understanding of spectroscopic techniques.
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• Experience in the use of computerized data handling systems.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
• Practical knowledge of organic structure, functional groups, chemistry, and modern spectroscopic techniques as applied to small-molecule analytical analysis.
• 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.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.