Kelly Services Principal Scientist - Injectables in Pine Brook, New Jersey
Principal Scientist, Injectables
Location: 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.
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.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
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