Solid Biosciences

Director

• Partner with the Company Team including Manufacturing, Quality, AD/QC, Regulatory, and PD as a manufacturing SME for our clinical manufacturing processes and provide direct Person-in-Plant on-site support during, minimally, all critical cell culture, purification, and drug product unit operations at CMO production locations.
• Drive GMP Compliance and evaluate all aspects of ongoing production and understand when to intervene on company’s behalf and when to escalate more significant issues for resolution.
• Work in close collaboration with the CDMO and internal teams to support manufacturing investigations and change controls.
• Provide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plans.
• Review and/or approve CDMO manufacturing documentation including manufacturing bill of materials, production master batch records, and executed production record review.
• Communicate routine production manufacturing status to company stakeholders and assist as necessary with process data retrieval, processing, analysis, through written, verbal, and presentation at various company meeting forums.
• Author key technical documentation supporting manufacturing activities including technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing process and controls.
• Author supporting documentation for relevant CMC manufacturing content of various regulatory submissions as needed.

Associate Director, MS&T