PROCESS CHEMISTRY CONSULTING SERVICES. KEY PERSONNEL CONSULTANT: DR. GIAN ARALDI.

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TO PROVIDE THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) BLUEPRINT NEUROTHERAPEUTICS NETWORK (BPN) WITH PROCESS CHEMISTRY CONSULTANT SUPPORT SERVICES Process Chemistry consultants will be expected to provide senior-level Process Chemistry expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the Process Chemistry consultant may include but is not limited to the following responsibilities and tasks: • Support process chemistry efforts of preclinical and clinical programs of the small molecules in development. Consultants may be asked to provide guidance on process endpoints, recommend assays and milestones to be incorporated into a testing funnel or development plan, and interpret data delivered by research service contractors. • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage process chemistry to support development of efficient and scalable manufacturing processes. • Provide expertise in process, scale up and implementation of innovative technologies, in support of IND enabling and clinical studies. • Serve as the process chemistry expert in order to identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines. • Lead the chemical development activities including scale-up and process development from pilot-scale to commercial scale and technology transfer to commercial plants. • Manage the process development technology transfer of projects at contract manufacturing sites. • Oversee the writing of protocols for the manufacture of scale-up batches and associated process development reports. • Lead the process chemistry activities for compounds in development in accordance with the US regulatory and the ICH guidelines. • Evaluate manufacturing processes and changes, assessment of regulatory implications. • Maintain current knowledge of the relevant guidelines and regulations.