AbbVie Senior Scientist II/III, Process R&D, Scientific Affairs in Lake County, Illinois

Senior Scientist II/III, Process R&D, Scientific Affairs

USA, Illinois, Lake County

Research & Development

Requisition #1803842

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.

Thisnon-laboratoryposition 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.

KeyResponsibilities:

Regulatory Submissions-Related:

  • Author Module 3 (Quality) documentsrelevant to drug substance manufacturing and controls for investigational newdrug applications and marketing applications and ensure consistency andscientific thoroughness of content

  • Author responses to informationalrequests from Health Authorities

  • Contributetoidentifyingsubmission-related risks and developing mitigation strategies with CMC team

  • Authorbriefing documents for meeting or advice requests with Health Authorities

  • Participatein relevant meetings with Health Authorities

Late-Stage Drug SubstanceDevelopment:

  • Participate in the development ofcontrol strategies and justification of controls for late-stage small moleculeand antibody drug conjugate development programs

  • Provide guidance to drug substancedevelopment teams on ICH guidelines and global regulatory expectations

  • Contribute perspectives based on priorexperience, feedback from Health Authorities, and benchmarking

Strategic Influence and ProcessImprovements:

  • Drive continuous improvements to Module3 content

  • Participate in industry working groups

  • Maintain knowledge of current industryand regulatory trends in CMC development and controls

  • Participate in Process R&D and CMCprocess improvement initiatives

Level and compensation will be commensurate with experience

  • Bachelors, Masters, or Ph.D. in Chemistry or ChemicalEngineering 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 manufacturingprocess development, control strategies, and regulatory/ICH guidelines

  • Experience with late-stage drug substance development

  • Demonstrated strong technical writing skills

  • Strong negotiation skills, oral and writtencommunication skills, and influencing skills

  • Demonstrated ability to collaborate with allied areas

KeyLeadership Competencies:

  • Builds strong relationshipswith peers and cross functionally with partners outside of team to enablehigher performance

  • Learns fast, grasps the'essence' and can change the course quickly when indicated

  • Raises the bar and is neversatisfied 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