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.
Manager, Process Chemistry will have responsibility for the management of API and solid oral dosage manufacturing operations at Insmed’s CMOs including tech transfer, process optimization, clinical/commercial manufacturing and ensuring the continued refinement and enhancements of the manufacturing process.
- Responsibility for the oversight of API and solid oral dosage manufacturing operations at Insmed’s CMOs. This includes real-time oversight of CMOs execution of tech transfer activities, scale-up, validation, batch manufacturing, technical support as Insmed’s internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets, and management of any process improvement related projects.
- A minimum of a MS or PhD in Pharmaceutical Sciences, Organic Chemistry, or a similar technical degree is required.
- A minimum of 6 years of experience managing pharmaceutical API manufacturing processes is required (preferably of products marketed in the US and EU).
- A minimum of 3 years of experience leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment is required.
- Experience managing CMO operations.
- Experience in NCE and solid oral dosage manufacturing (total synthesis, physical organic chemistry, roller compaction, tableting).
- Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.
- Sound awareness of Regulatory, Quality Assurance, and cGMP requirements
- High energy, innovative “can do” attitude is required.
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Strong verbal and written communication skills are essential.
- Potential for 20% travel