- AbbVie (North Chicago, IL)
- …with respect to science, time, budget and resources. + Develops and implements a CMC product development plan and updates as necessary in collaboration ... thinking and make smart business decisions. *Ensure high level of morale in the CMC team. Product development experience of leading a CMC team through… more
- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- AbbVie (North Chicago, IL)
- …experience; PhD Degree with at least 10+ years of relevant experience. + CMC development experience through IND and/or NDA/MAA/BLA. Experience leading multiple ... about the accountability and scope. + Lead cross-functional PDS&T product teams and represent the CMC team...Bachelor 's Degree with 14+ years of relevant experience ( CMC , sterile manufacturing/ development ); Master's Degree with 12+… more
- AbbVie (North Chicago, IL)
- …respect to time and budget. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard ... the clinical/regulatory development strategy and provide drug development experience and advice to the CMC ...planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission… more
- Lundbeck (Deerfield, IL)
- …process and efforts to harmonize US and global processes, to ensure the successful development and approval of product labelling, as well as compliant lifecycle ... Director US Regulatory Global Strategic Labelling - Remote...process. + Partners with cross functional team to ensure development of target product labelling, as well… more