Director, Cell Therapy
vor 2 Monaten
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Functional Area Description**
The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.
**Position Summary / Objective**
The CMC Regulatory Director, Cell & Gene Therapy
- Emergency Response/Next Generation Acceleration / Policy will provide CMC regulatory strategic direction for the cell therapy enterprise business management of unforeseen events in the chemistry, manufacturing, and control of the company’s cell and gene therapy assets.
The CMC Regulatory Director will also provide the regulatory CMC strategy for the company’s Next Generation Acceleration (NGA) initiative and will sit on the Next Generation Acceleration Team. In addition, the position will actively work with the Global Regulatory Policy group in actively participating and leading in the creation of global policies and regulatory frameworks for cell and gene therapy. The position will collaborate with cross functional stakeholders in providing the company’s position on global cell therapy policies and guidance documents
**Position Responsibilities**
- Use executive presence to establish credibility within the organization and partner with senior leaders across the cell & gene therapy franchise, cell & gene therapy development / operations, clinical, medical, quality, regulatory, legal, etc. to brainstorm and execute sound Regulatory CMC strategies in response to unforeseen cell/gene therapy CMC events.
- Work with internal and external stakeholders to influence cell/gene therapy global policies
- Provide regulatory CMC strategy and leadership to the Next Generation Acceleration (NGA) team
- Independently manage and prioritize multiple complex projects
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Identify, communicate, and propose resolutions to routine/complex issues
- Interpret global regulations and guidance. Identify regulatory opportunity and risks.
- Anticipate and communicate possible regulatory paradigm shifts
- Participate in product fact finding meetings
- Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documents
- Mange relationships with diverse teams
- Utilize electronic systems for dossier creation and tracking.
**Degree Requirements**
- Minimum BA/BS Degree
**Experience Requirements**
- Minimum of 10+ years pharmaceutical industry experience - prefer knowledge of biotechnology / cell & gene therapy products, including multi-disciplined experience, 7+ years CMC regulatory strategy (biologics/cell therapy experience preferred).
- Demonstrated ability to develop/maintain strong working relationships with Senior Leaders, cross functional teams, participate on and/or lead multifunctional teams, handle, and prioritize multiple projects and work independently.
- Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell & gene therapy compounds preferred.
- Expertise in the cell &gene therapy drug development process and analytical methods.
- Ability to identify, communicate and resolve complex issues. Ability to interpret global regulations and guidance.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
**COVID-19 Information**
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your ar
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