Bristol Myers Squibb Manager CMC Biologics in Hopewell, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Represent regulatory CMC on matrix teams while providing strategic guidance related to current regulatory requirements and expectations for marketing applications and clinical trial applications for small molecule projects, potentially including drug/device combination products
Review and provide regulatory assessments on change controls
Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
Manage relationships with diverse teams
Utilize electronic systems for dossier creation and tracking
Education, Experience, Skills:
Minimum of Bachelor's Degree, scientific discipline, with minimum of 4-6+ years of related experience
CMC regulatory experience desired
Knowledge of CMC regulatory requirements during development and post-approval
Knowledge of pharmaceutical development, including drug substance and drug product and analytical methods. Drug/device combination product experience desired.
Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness
Ability to interpret global regulations and guidance
Strong oral and written skills
Proficient with electronic systems
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.