Research Scientist/ Research Investigator
Designs and authors stability protocols, authors stability reports and stability sections of filings to support clinical use and registration of biologics drug substances and products.
- Effectively and independently designs and authors stability protocols based on knowledge of global stability guidelines to support clinical use and registration of biologics drug substances and products.
- Analyzes and trends stability data. Independently identifies issues and works with development team to resolve them. Clearly and effectively summarizes and presents results from stability studies and authors technical memos and reports.
- Contributes to scientific and technical discussions with team members and external collaborators to resolve issues and communicate conclusions from stability studies.
- Authors the stability section in investigational and registrational global filings. Develops strategy and authors responses to stability-related questions from health authorities within the established timelines.
- Proposes label storage statement and shelf life for drug substance and drug product.
- Manages protocol and stability data reports in LIMS.
- Serves as the stability subject matter expert in development teams through global registrations.
- BS/MS/PhD in chemistry, pharmacy/pharmaceutical sciences, or biochemistry
- 4 or more years of experience in the pharmaceutical industry, with experience in designing and writing stability protocols for investigational or registrational, studies for biologics, and in analyzing large sets of data.
- Applies ICH guidelines and other global regulations as they relate to stability to design complex, phase-appropriate stability protocols to support the intended purpose. Guides teams in establishing the stability strategy for the asset.
- Applies understanding and knowledge of pharmaceutics, pharmaceutical development and global stability guidelines to the development of stability protocols and the analysis of stability data. Serves as the stability SME in development teams.
- Analyzes large sets of biologics stability data and understands biologics laboratory test methods
- Authors stability sections of CTA's and registrational filings. Responds to health authority questions.
- Strong technical-written and verbal communication skills.
- Ability to prioritize and manage multiple large projects simultaneously and complete deliverables within established timelines.
- Understands documentation practices required for a cGMP regulated environment.
- Works independently in a complex, fast-paced, deadline driven environment