Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
This position will have responsibility for quality assurance oversight of clinical/commercial development of inhalation medical devices for drug product delivery.
• Provide technical expertise in their area of specialization (i.e., Inhalation Devices, Device Development, etc.).
• Qualification of vendors with a focus on those in the device related supply chain. Selection, development and characterization of Nebulizers, Metered dose/dry powder inhalers, or similar for both clinical and commercial scale.
• Work with external contractor/vendor network to ensure on-going quality and compliance. This would also include periodic audits.
• Member of a dynamic scientifically driven team, dedicated to the development and optimization of inhalation devices.
• Perform internal audits and reviews to insure Insmed maintains compliance with applicable device regulations and regulatory agency expectations.
• Review manufacturing batch production records and perform release of products.
• Track CAPAs and ensure proper closeout and documentation.
• Review technical reports, relevant CMC sections, and oral presentations.
• Bachelor’s degree (advanced degree preferred) with a minimum 7 years of experience in a Quality Assurance function within the pharma/biotech industry required.
• Hands-on experience with devices, including nebulizers and MDIs is highly desirable.
• Strong background in pharmaceutical development as it relates to inhalation devices.
• Working knowledge of quality systems, Quality by Design, validation principles, engineering design, DOE, and statistical process control fundamentals.
• Working knowledge of cGMPs during pharmaceutical development and commercial manufacturing.
• Experience auditing and qualifying outside vendors and CMOs.
• Sound awareness of Regulatory, Quality Assurance, and cGMP requirements, particularly in the inhalation field.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
• Strong verbal and written communication skills are essential.
• High energy, innovative “can do” attitude is required.