Insmed Incorporated - Bridgewater Township, NJ
posted about 1 month ago
The Manager, Combination Product Development at Insmed plays a crucial role in supporting the design and development activities for new combination products. This position is integral to ensuring that the products meet the necessary regulatory and quality standards while also addressing the needs of patients with serious and rare diseases. The manager will be responsible for generating process, product, and life cycle-related metrics through statistical analysis, which is essential for informed decision-making and continuous improvement in product development. In addition to metrics generation, the role involves conducting risk assessments and maintaining a comprehensive risk management file, including an annual review of the User Failure Mode Effects Analysis (UFMEA). The manager will also be tasked with creating and maintaining the design history file for new products, which is a critical component of the product development lifecycle. Coordination of characterization studies and collaboration with cross-functional teams to develop user requirements and design inputs are also key responsibilities. The manager will lead complaint investigations related to combination products and serve as the primary point of contact for the device manufacturer, organizing regular technical meetings to ensure alignment and address any issues that arise. Drafting Investigational New Drug (IND) submissions for the combination product and performing technical assessments for device changes are also part of the role. The manager will oversee the change control process and schedule design reviews to ensure that all aspects of the product development are thoroughly evaluated. Additionally, the manager will represent the team in Chemistry, Manufacturing, and Controls (CMC) meetings, assessing the impact of device and combination product changes. This position requires a proactive approach to project planning for combination product development activities and effective collaboration with cross-functional team members to achieve project goals.