Skip to main content

Search jobs

Search jobs

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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Principal Research Scientist I, Process R&D Scientific Affairs

Lake County, Illinois Req ID 2200115 Category Research and Development Division AbbVie

AbbVie Process R&D group is seeking an experienced and dynamic Principal Scientist to join its Scientific Affairs group. As a member of drug substance development teams, Scientific Affairs collaborates closely with team members to advance AbbVie’s small molecule and antibody drug conjugate pipelines through the development of manufacturing control strategies, CMC strategy, and preparation of related regulatory submissions.

This is a non-laboratory position where scientists with experience in drug substance process development will contribute their broad knowledge to AbbVie drug substance teams while gaining subject matter expertise in a new field. Strong candidates are those with experience in late-stage drug substance development with an emphasis in process chemistry, process engineering, or process analytical.

Key Responsibilities

Late-Stage Drug Substance Development:

  • Contribute to the development of control strategies and justification of controls for late-stage small molecule and antibody drug conjugate development programs
  • Consult with drug substance development teams on ICH guidelines and global regulatory expectations.
  • Provide perspectives based on prior experience, feedback from Health Authorities, and benchmarking.

 Regulatory Submissions:

  • Author Module 3 (Quality) documents relevant to drug substance manufacturing and controls for investigational new drug applications and marketing applications and ensure consistency and scientific thoroughness of content
  • Author responses to informational requests from Health Authorities
  • Contribute to identifying submission-related risks and developing mitigation strategies with CMC team
  • Author briefing documents for meeting or advice requests with Health Authorities
  • Represent Process R&D in relevant meetings with Health Authorities

Strategic Influence and Process Improvements:

  • Drive continuous improvements to Module 3 content
  • Represent AbbVie in industry working groups
  • Maintain knowledge of current industry and regulatory trends in CMC development and controls
  • Participate in Process R&D and CMC process improvement initiatives



*Level and compensation will be commensurate with experience*

  • Bachelors, Masters, or Ph.D. in Chemistry or Chemical Engineering with a minimum of 12-14 years (BS), 10-12 years (MS), or 4-6 years (Ph.D.) of relevant pharmaceutical development experience.
  • In-depth knowledge of drug substance manufacturing process development, control strategies, and regulatory/ICH guidelines
  • Experience with late-stage drug substance development
  • Demonstrated strong technical writing skills
  • Strong negotiation skills, oral and written communication skills, and influencing skills
  • Demonstrated ability to collaborate with allied areas

Key Leadership Competencies:

  • 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 the course quickly when 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: No
Job Type: Experienced
Schedule: Full-time

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Research and Development, Lake County, Illinois, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation