AbbVie

Principal Research Scientist, Analytical Chemistry

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Nov 18, 2020
Ref
2008602
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Analytical chemist responsible for commercial and pipeline small molecule development within Science and Technology, Pharmaceutical Product Group.

Major Responsibilities:
  • Develop analytical strategies for late stage new product development. Communicate the strategies and plans to Analytical Teams and S&T CMC teams for execution. Direct experimental and project activities as the lead of a team to achieve project goals to support new product regulatory filing and launch.
  • Supervise a team of analytical scientists for method development, validation, transfer and monitoring analytical method performance as well as continuous improvements according to the development plan.
  • Collaborate with other functions in R&D and Operations globally to support drug substance and drug product development and manufacturing activities to ensure the new product launch and commercial supply.
  • Provide analytical leadership in commercial product investigations. Identify and resolve issues using analytical technologies and drug development experience. Interact with Quality and manufacturing site as the analytical lead in formulating decisions and present to management.
  • Interpret and identify data trends in key analytical release and stability assays.
  • Proactively advise and share knowledge/expert opinions with peers and management. Mentor peers in project management and development of analytical strategies.
  • Author and/or review key regulatory documents, laboratory data, technical memos and reports.
  • Demonstrate scientific excellence in analytical characterization and development for small molecules or natural products.
  • Generate innovative ideas and implement in project activities. Contribute to department technology development by introducing new analytical technologies or approaches
  • Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Qualifications

Qualifications:
  • BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typical 12+ years of experience; PhD with typical 6+ years of experience in Chemistry or related fields with previous work experience (6+ years) in a pharmaceutical development laboratory setting. Advanced degree is strongly preferred.
  • Preferred candidate should have experience in leading analytical development activities for new drug development.
  • Experience in analytical technologies (HPLC, GC, UPLC, spectroscopy, dissolution, compendial tests, and wet chemistry).
  • Experience preferred in compound characterization, such as physicochemical properties.
  • Previous supervisory experience of laboratory staff and leading analytical projects preferred.
  • Experience in DS/DP control strategy and specification development required.
  • Experienced in laboratory systems (LIMS, ELN) preferred.
  • Knowledge in relevant ICH and regulatory guidance is required and experience in interactions with regulatory agencies is preferred
  • Knowledge of designing stability studies and analytical experiments required
  • Track record in leading analytical development teams

Key AbbVie Competencies:
  • Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators 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.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.