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

Qualifications

Basic: 

*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