Senior Scientist, Process R&D Scientific Affairs (Regulatory)

Employer
AbbVie
Location
North Chicago, IL, US
Posted
Dec 05, 2018
Ref
1808337
Required Education
Bachelors Degree
Position Type
Full time
The Process R&D group is seeking a highly motivated Senior Scientist to join its Scientific Affairs group. Scientific Affairs is a member of the drug substance development teams that advance AbbVie's small molecule and antibody drug conjugate pipelines.

This non-laboratory position is an excellent opportunity for scientists with experience in drug substance process development to apply their broad knowledge to regulatory submissions, control strategy development, and CMC strategy. Candidates with experience in drug substance development with an emphasis in process chemistry, process engineering, or process analytical are encouraged to apply.

Key Responsibilities:

Regulatory Submissions-Related:

  • 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
  • Participate in relevant meetings with Health Authorities


Late-Stage Drug Substance Development:

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


Strategic Influence and Process Improvements:

  • Drive continuous improvements to Module 3 content
  • Participate 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


Basic:

*Level and compensation will be commensurate with experience*

  • Bachelors, Masters, or Ph.D. in Chemistry or Chemical Engineering with a minimum of 12 years (BS), 10 years (MS), or 4 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


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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