Bristol Myers Squibb Senior Manager I, CMC Regulatory, Cell & Gene Therapies in Seattle, Washington
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The CMC Regulatory Senior Manager I, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory & Safety Sciences (GRSS) & Cell Therapy Development Operations (CTDO). The CMC manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management & must have proficiency in electronic systems
Minimum of 3 years CMC regulatory experience specifically in cell &/or gene therapies & a minimum of 5 years CMC regulatory experience in total. A minimum of a BA/BS in scientific discipline required; advanced degree in scientific discipline preferred (MS, Ph.D., PharmD).
Knowledge of CMC regulatory requirements for advanced therapies and/or biologics during development and post-approval.
Knowledge of pharmaceutical development, including advanced therapies and/ or biologic upstream and downstream processes, analytical methods, and biologic/device combination products.
Demonstrated ability to develop/maintain strong working relationships 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 documents.
Strong oral and written skills.
Proficient with electronic systems
Support project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.) for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions.
Provide strategic CMC regulatory expertise for development project teams
Provide strategic input to development & GO teams to mitigate drug supply issues.
Interpret global regulations and guidance.
Identify, communicate and propose resolution to routine issues.
Participate in product fact finding meetings
Interface with the US FDA for CMC submissions and CMC-related issues (either with the USL or directly)
Communicate with project teams; in particular with regards to technical issues that may impact regulatory submissions, strategy, or success.
Provide technical teams insight into regulatory health authority expectations
Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success
Ensures the necessary updates are provided to team leaders (CMCL, GRTL, Line manager etc.)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1546858
Updated: 2021-09-22 03:12:29.975 UTC
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.