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Director/Manager/CMC Process Development Scientist

Company: Arrowhead Pharmaceuticals
Location: Madison
Posted on: January 16, 2020

Job Description:

The PositionWe seek a scientist and team leader in our Madison, WI location to provide expertise and leadership in the development of new pharmaceutical products with external contract manufacturing organization (CMO) partners. The successful applicant will work with internal research chemists and research associates to learn and translate synthetic methods from our research labs for process development and manufacturing scale up of Drug Substance (API) and Drug Product at external CMOs to support Arrowhead drug development programs. S/he will provide technical leadership and troubleshooting during development, manufacture, release, and stability testing of oligonucleotide-containing development candidates.--S/he will prepare and deliver technical reports and documents in preparation for regulatory submissions and work with Quality Assurance and other functional areas to ensure appropriate application of key guidance, procedures and policies throughout development and commercialization.--Requirements:--PhD in Chemistry, or Chemical Engineering with demonstrated in-dept scientist knowledge and experience (7+ years for group leader, 10+ years for director) in pharmaceutical development--Experience in small molecule API process development towards late phase API manufacture--Experience in working with external CMOs--Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought designing experiments and research strategy--Excellent written and verbal communication skills with ability to multi-task--Experienced with cGMP practices and ICH/FDA guidance documentsHighly motivated team player willing to contribute to a growing biotech organization--Preferred:--Hands-on experience and in depth knowledge in the development of oligonucleotide (e.g. siRNA, antisense) based drugsFamiliar with analytical method development to support early drug developmentFamiliar with stability testing and experience in completing the CMC aspects of regulatory submissions--Familiar with bioconjugation

Keywords: Arrowhead Pharmaceuticals, Madison , Director/Manager/CMC Process Development Scientist, Executive , Madison, Wisconsin

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