- 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
- AbbVie (North Chicago, IL)
- …operational excellence within Biologics Analytical R&D and in line with the Biologics CMC Development /AbbVie strategy for NBEs. + Recruit, promote, and retain ... interfaces with other functions inside and outside of Biologics CMC Development and R&D. + Assures compliance...experience in leading a biologics drug substance and/or drug product development organization across different levels and… more