Forge Biologics
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The Scientist I in Analytical Development will design and execute protein-based assays for gene therapy products, develop protocols, troubleshoot issues, analyze data, and collaborate with teams. Responsibilities also include assay transfer activities, regulatory documentation preparation, and training junior team members.
The Associate Scientist II supports the development and optimization of protein-based assays for AAV gene therapy products, executing complex assays, collaborating with teams, and ensuring product quality. Responsibilities include method development, data analysis, mentoring, and assisting in regulatory documents preparation.
The Sr. Manager, Quality Assurance will oversee the Quality Assurance team, ensuring compliance with GMP regulations, authoring and approving quality documentation, and leading continuous improvement initiatives. They partner with technical groups to resolve quality issues, effectively communicate quality concerns, and support internal and external audits.
The IT Project Manager oversees and manages IT-focused projects across various departments, ensuring project goals align with business objectives. Responsibilities include developing project plans, coordinating cross-functional teams, managing risks, and ensuring compliance with industry regulations while providing user training and support.
The Staff Accountant will manage day-to-day accounting activities, including accounts payable, general ledger entries, month-end closing, and inventory accounting. Responsibilities include verifying invoices, assisting with audits and SOX reviews, creating accruals, and supporting the implementation of internal controls and NetSuite. The role requires adaptability to change and a growth mindset within the finance department.
The Quality Engineer I will ensure quality oversight of engineering and validation deliverables at Forge, focusing on GMP compliance and documentation for drug product manufacturing. Responsibilities include reviewing calibration and validation documents, performing risk analyses, aiding quality investigations, and supporting audits.
Manage a portfolio of client projects in the gene therapy field, focusing on development and manufacturing stages. Responsible for project planning, communication with teams and clients, financial tracking, risk management, and documenting project activities while ensuring quality standards are met.
Drive the development of cell-based AAV gene therapy potency assays, requiring skills in cell culture and assay method development. Responsibilities include designing biological assays, evaluating cell culture models, performing in vitro potency assessments, and maintaining lab records. Collaborate with cross-functional teams to advance AAV vector production and ensure compliance with regulatory standards.
The Supply Chain Planner will contribute to operational and supply chain activities for gene therapy manufacturing, assisting in forecasting, managing inventory, and optimizing resource planning, while ensuring alignment with organizational strategies and collaborating with cross-functional teams.
As an Associate Scientist I in Analytical Development, you will execute tests for AAV gene therapy and plasmid products, prepare reagents, perform data analysis, and assist in assay optimization while adhering to safety protocols and collaborating with cross-functional teams.
The Senior Scientist in Process Development will lead the development and optimization of AAV manufacturing processes, providing technical expertise in bioreactor operation and cell culture. This role involves managing complex experiments, mentoring junior staff, and contributing to project leadership and process optimization initiatives.