Senior Scientist, Process R&D/Regulatory – Global Biopharma - Chicago Suburbs
Job Summary Meet is working with a leading pharmaceutical company headquartered in the Chicagoland area on a Senior Scientist role within their Process R&D group. This position will lead continuous improvement in Process R&D and Module 3 content, putting you in a high-profile position in late stage drug development.
Job Overview Responsibilities Include:
• Lead, provide guidance to, and participate in control strategy development and controls justification for drug development programs
• Collaborate with CMC team in order to identify and mitigate submission-related risks
• Work with the needs of external health authorities, writing responses to requests, authoring briefing documents, and participating in meetings as needed
• Lead and participate in Module 3 content creation, including authoring all relevant documents
Skills Required • 10-15 years of relevant experience, MS or PhD strongly preferred
• CMC experience required
• Experience with late stage drug development required
• Demonstrated knowledge of drug substance manufacturing processes, process development, regulatory/ICH guidelines, and control strategies required
• Ability to work cross-functionally and communicate effectively both orally and in writing
Contact Details A full job description and details available upon application! This position is being dealt with by Hadley at Meet, call on 872-356-8144 or email directly at firstname.lastname@example.org for a confidential discussion.