Scientist - Organic Chemistry - Job ID:6022
- Responsible for setting project strategies, defining project responsibilities and timelines, providing leadership in a matrixed team setting and developing robust processes for cGMP manufacturing.
- Conceive of and develop synthetic routes for early-stage clinical deliveries, demonstrate processes in the API Pilot Plant, develop commercial manufacturing processes, establish commercial control strategies, and transfer processes to commercial manufacturing sites
- Interactions with organic chemists, analytical chemists, engineers, solid state scientists, drug product development, and program management.
- Collaborate with Asset Development Teams to advance clinical candidates.
- Utilize his/her expertise across CMC disciplines to further program goals via collaborations with drug product development, regulatory affairs, and commercial operations.
- A BS, MS, or PhD in chemistry with 10+ (BS), 5+ (MS), or 2+ (Ph.D) years of relevant experience required.
- GMP experience is a must have
- Strong knowledge of modern synthetic organic chemistry and drug development processes
- Strong understanding of process development, control strategy development, regulatory starting material strategies, specification setting, tech transfer and process validation requirements.
- Understanding of global regulatory expectations and experience authoring development reports and regulatory submissions is highly desirable.
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Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
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