Senior Manager, Global Regulatory Sciences-CMC, Cell Therapy

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.

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. Read more: careers.bms.com/working-with-us

Functional Area Description

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program, and provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain databases to address external questions regarding drug products.

Position Summary/Objective

The CMC Regulatory Senior Manager, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support cell therapyproducts regarding: Clinical trial applications; new marketing applications; HA responses and background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Senior Manager, Cell Therapy, will serve as the primary interface between Global Regulatory Sciences (GRS) and Cell Therapy Development. The GRS-CMC Senior Manager will assess manufacturing change controls for global impact and guide technical teams on practical aspects of global change management.

Product Responsibilities

• Represent regulatory CMC on and/or lead matrix teamsfor pipeline products and/or commercial products through the completion of post-marketing commitments and relevant lifecycle management projects driven by research and development
• Independently provide strategic guidance/input related to current regulatory requirements and expectations for marketing applications, clinical trial (including GMO) applications for projects, and/or lifecycle changes to marketed products
• Independently manage and prioritize multiple complex projects
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from the supervisor on complex topics
• Identify, communicate, and propose resolutions to routine/complex issues
• Interpret global regulations and guidance. Identify regulatory opportunities and risks
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact-finding meetings
• 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

Degree Requirements

Minimum BA/BS Degree

Experience Requirements

• 3 - 6 years of pharmaceutical industry experience – prefer knowledge of cell and gene therapy and / or biotechnology / biologics products, including multi-disciplinary experience, 2-4+ years of CMC regulatory strategy (cell therapy experience preferred).
• Knowledge of CMC regulatory requirements during development and post-approval.Experience with global CMC regulations for advanced therapies and biological compounds preferred.
• Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product, and analytical methods. Expertise in cell therapy and biologics drug development process and analytical methods, is preferred.
• 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 complex issues.
• Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
• Ability to interpret global regulations and guidance.

CA Residents Only:

The starting compensation for this job is a range from $130,794.00 - $153,876.00 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.

Final individual compensation will be decided based on demonstrated experience.

For more on benefits, please visit our https://careers.bms.com/working-with-us.

Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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