Regulatory

  • location: North Chicago, IL
  • type: Permanent
  • salary: $75 - $80 per year

job description

Regulatory

Job Title: Senior Scientist, Regulatory Submissions
Position Description
  • 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 the company's small molecule and antibody drug conjugate pipelines.
  • Non-Laboratory environment
  • 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.
  • Ideal candidate has experience in drug substance development with an emphasis in process chemistry, process engineering, or process analytical.
  • 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
Position Responsibilities
  • 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
Position Requirements
  • 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 area
  • Late stage trial experience
  • CMC Experience
  • Drug Substance / API development experience
Benefits
  • Full Package
  • Relocation Assistance Available, if needed

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