Insmed Incorporated - Bridgewater Township, NJ
posted about 2 months ago
The Manager, Combination Product Development at Insmed Incorporated 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 individual in this role will be responsible for generating process, product, and life cycle-related metrics through statistical analysis, which is essential for informed decision-making throughout the product development process. In addition to metrics generation, the Manager will conduct risk assessments and maintain a risk management file, including an annual review of the User Failure Mode and Effects Analysis (UFMEA). The role also involves generating a design history file for new products and coordinating characterization studies, which are vital for understanding product performance and safety. The Manager will work closely with cross-functional teams to develop user requirements and design inputs, ensuring that all aspects of the product development align with regulatory expectations and user needs. Another key responsibility is leading complaint investigations related to combination products and/or devices, acting as the primary point of contact for the device manufacturer. This includes organizing regular technical meetings to facilitate communication and collaboration. The Manager will also draft Investigational New Drug (IND) submissions for the combination product and perform technical assessments of device changes, owning the change control process. Scheduling and coordinating design reviews, project planning for combination product development activities, and performing technical reviews of labeling, Instructions for Use (IFU), and training material changes are also part of the role. The Manager will represent the team in Chemistry, Manufacturing, and Controls (CMC) meetings, assessing the impact of device and combination products on overall project goals. This position requires a proactive approach to working with cross-functional team members to ensure successful product development and compliance with industry standards.