Principal Scientist, InjectablesDirect HireLocation: Pine Brook, NJ
The Principal Scientist is responsible for the development of complex injectable dosage forms including formulation development, process development, technical transfer, and commercial product support. The complex injectable products include long acting/peptides/drug-device combination injectables.RESPONSIBILITIES
- Design and execute R&D batches through Quality by Design (QbD) approach
- Conducts scientific literature search.
- Identify key process parameters and their impact on product quality
- Lead the development plan to address scale up and tech transfer issues
- Develop and execute scale up/tech transfer and submission batches.
- Reviews data, performs root cause analysis for trouble shooting and seek path forward under advisement
- Document preparation and review such as batch records, protocols, sampling plans, engineering reports and qualification reports
- Prepare and/ or review product development reports, process development report and other relevant documents as required for ANDA filing
- Be Proactive, have good organizational and time management skills
- Support and drive the project to targeted timelines with the manufacturing site for a timely and successful product filing
- Complete all required in-house and external training to keep current on regulatory and industry changes
- Must be able to work in a cross-functional environment interacting with departments such as tech services, analytical, regulatory, biopharmaceutics, quality, and project management.
- Ph.D. with 5 years or MS 8 years of formulation and process development experience in generic industry, especially in injectable dosage forms.
- Working experience in the development of complex injectables such as peptides, sensitive APIs and long acting injectables.
- Experience in drug device combination products is a plus.
- Strong oral and written communications skills
- Proficient in computer use (Word, Excel, PowerPoint) with ability to learn new computer applications
- Ability to follow standard operating procedures to perform work function.
- Strong technical aptitude, sound judgment and operates with a sense of urgency in a fast-paced environment
- Up to date information and knowledge of FDA's requirements for ANDA's cGLP, cGMP related to pharmaceutical product development, manufacturing, and documentation
- Experience and understanding of Design of Experiments (DOE), Quality by Design (QBD), scale-up and process technologies
- Experience in working with CRO/CMO is a plus
- Must be able to travel. Travel up to 30% domestic and could have some International.