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Responsible for development of liquid and freeze-dried formulations of all commercial and clinical products.
This position will help manage the overall accounting and processes related to inventory and cost of sales in a manufacturing environment. This person will support the creation, implementation, and management of the Company’s inventory and cost accounting processes, policies, and documentation as it transitions to commercialization. This person will assist in the implementation and maintenance of a new ERP system. As the process owner and subject matter expert, working in partnership with supply chain, manufacturing, quality and manufacturing support, this person will ensure the ERP implementation is completed timely and accurately. The scope of the implementation will include Bill of Material, Routings and Recipes.
Upon commercialization, this position will be responsible for managing the accounting for inventory, cost of sales, supply chain processes, ensuring compliance with GAAP, SOX, and SEC requirements. This position includes inventory documentation, accounting and analyses, inventory cost validation, P&L analysis and reporting, and forecasting. This person will work closely with our supply chain, commercial operations team, 3rd party logistics provider, and will interact directly with our external auditors.
Supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight of the quality management system development and maintenance in support of phase I-IV clinical trials. Must be comfortable and thrive in biotech small company, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient to effectively manage multiple projects and responsibilities concurrently.
Responsible for leading the Drug Product development and validation of all commercial and clinical products under cGLP and cGMP guidelines.
The Senior IT Business Analyst is responsible for business analysis within the GMP Manufacturing and Quality business technology area, supporting global Supply Chain, Manufacturing, Quality, and other Operations support functions. The position is responsible for overseeing activities for gathering, analyzing and prioritizing functional and non-functional requirements to facilitate the development of systems or technical solutions for complex business issues. This includes development of comprehensive domain business process models used to guide continuous improvement initiatives and overall understanding of the business processes key to Operations. The Senior Business Analyst works closely with key business stakeholders, SME’s, IT peers, validation and other team members to identify and document business requirements needed to identify possible solutions for data, processes, interfaces, controls, systems, outputs, etc.
The Senior IT Business Analyst Operations and Quality will work in partnership with other domain business analysts in the development of best practices, standardized templates and business analyst methodologies to be practiced across the organization.