• Monitor timelines of CMC tasks, manufacture of drug substance, drug product, toxicology and regulatory documentation for GMP programs and IND-enabling tasks • Construct charts for programs, maintain project files and reports in SharePoint and other databases • Monitor activities for timely delivery of goods, reports, and projects-related data.• Provide oversight and management of SharePoint directories for each client program with checking/review of files for completeness • Create proposals and follow up with POs issued by clients in consultation with upper management• Ensure good working relationships with Clients and CRO/CMO suppliers

Scientific documentation reviewer/auditor of Current Good Manufacturing Practices (CGMP) and testing procedures for transdermal delivery systems• Review GMP manufacture of clinical and commercial drug products including manufacture of DEA controlled substances• Ensure compliance of drug product manufacturing activities and verify batch release with CGMP regulations and policies, generate CofC when required• Provide analytical data review for Raw Materials, Drug Substance, Drug Product, and stability testing• Complete transactions in SAP QM Module, Access database, and maintain systems for organizing, tracking, and reporting batch disposition and review • Write and revise Standard Operating Procedures (SOP) and guidelines• Identify and resolve documentation errors and questions, assign and investigate Quality Alert Notices, Deviations and CAPAs when required• Assist with technology transfer projects in the support of early phase investigational products; technical and stability, clinical drug products and those transitioning to commercial stage • Review CMO documents including protocols for manufacturing process development/transfer, GMP manufacturing, process validation and performance qualification• Collaborate effectively with CMO project management and external customers to ensure quality standards are met and issues are resolved promptly and effectively• Manage and coordinate review and approval of production batch records and the supporting documentation to ensure timely release of final drug product• Review manufacturing deviations and investigations of any environmental/utility excursions or out-of-specification results

• Scientist with pharmaceutical experience in preclinical research and development with a proven record of flexibility and adaptability.• Knowledge of FDA drug regulatory laws, regulations and guidelines (cGMP, GLP, ICH GCP). • Accomplished scientific and technical writer with four published papers, three patents, and several posters• Thorough understanding of regulatory submission documents (IND,NDA, CMC Module 3 of CTD)• Ability to accurately and clearly interpret and present scientific data results both in writing and orally • Performed research in Inflammation, Autoimmune, Metabolic diseases, and Oncology therapeutic areas• Expertise in information searching using scientific and commercial databases (SciFinder, Reaxys, etc.)• Interacted with cross functional teams and CROs• Contributed to the project that delivered clinical candidates for Type 2 Diabetes• Demonstrated high level of accuracy preparing experimental sections for patent applications ; reviewed for accuracy, consistency and completeness • Effectively utilized electronic record management systems for data entry and data retrieval • Organized, detail-oriented, and able to prioritize effectively to accomplish multiple tasks • Proficient with Microsoft Office applications, Adobe Acrobat, MS Project, Access, and multiple database systems