Jennifer Rosser
About Jennifer Rosser
Jennifer Rosser is a Sr. Technical Writer at Bristol Myers Squibb with extensive experience in good manufacturing practices and regulatory submissions.
Company
Jennifer Rosser is currently employed as a Senior Technical Writer at Bristol Myers Squibb. She brings her extensive experience and skills in technical writing and regulatory submissions to the company. Bristol Myers Squibb is a globally renowned pharmaceutical company focused on discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
Title
Jennifer Rosser holds the position of Senior Technical Writer. Her role involves specializing in the technical aspects of writing for regulatory submissions, including the Chemistry, Manufacturing, and Controls (CMC) sections for Investigational New Drug (IND) and Biologics License Application (BLA) filings.
Education and Expertise
Jennifer Rosser has an extensive educational background with a Master's degree in Immunology from the University of Washington, which she completed between 1993 and 1996. She also holds a Bachelor of Science degree in Biology and Chemistry from Caltech, awarded after her studies from 1989 to 1993.
Background
Jennifer Rosser has a significant professional history with a prior role as Senior Manager of Quality Control at ZymoGenetics, where she worked for 21 years from 1997 to 2018. Her extensive background includes proficiency in good manufacturing practices (GMP) for both clinical and commercial product support, conducting laboratory and Out of Specification (OOS) investigations, and developing method validation protocols and reports.
Technical Writing and Method Validation
Jennifer Rosser specializes in technical writing for regulatory submissions, such as the Chemistry, Manufacturing, and Controls (CMC) sections for IND and BLA. She is proficient in writing Standard Operating Procedures (SOPs) and analytical test methods. Her expertise extends to developing method validation protocols and reports as well as method transfer protocols and reports. Additionally, she has created product specifications and manufacturing sample plans.
Laboratory Skills and Methodology
Jennifer Rosser possesses a strong background in laboratory methodologies and equipment validation. She is experienced in antibody generation, cell culture techniques, performing ELISA, and cell-based bioassays. She also has substantial experience in compendial and chemical methods, developing enzyme activity assays for research and development projects, and transferring analytical methods to collaborators while training in-house staff.