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Director, Regulatory CMC - Cell Therapy
Bristol Myers Squibb
USA
Full-time
Director · 10+ years experience
Onsite
Discovered 3 weeks ago
Role Overview
The starting pay range(s) listed above is for full-time employees (FTE).
You may also be eligible for additional discretionary incentive cash and stock opportunities.
We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring.
Final compensation is guided by pay equity principles and applicable employment laws.
Full Job Posting
Qualifications
- Minimum BA/BS Degree
- Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience
- Key Competencies:
- Knowledge of CMC regulatory requirements for advanced therapies and/or and cell therapy during development and post-approval as applicable
- Knowledge of pharmaceutical development, including advanced therapies and/ or, biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products as applicable
- Ability to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
- Ability to interact with CMC technical experts regarding technical issues such as those related to process development and analytical
- Understanding of scientific content and complexities and good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration
- Experience leading cross-functional teams, demonstrated ability to drive quality decision-making and ability to organize / prioritize tasks
- Demonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict management
- Direct experience in developing strategy and leading teams through interactions with health authorities, track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components
- Strong understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval
- Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment; looks for opportunities for continuous improvement
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
- Communicates opinions, facts and thoughts with clarity, transparency, and honesty and sets clear and high expectations and holds self and others accountable for decisions and results achieved. Demonstrates ownership of results within (and beyond) area of responsibility
- Experience as a member of the CMC Team, GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
- Ability to broadly represent department functions on project team in a matrix organization
- Seeks multiple perspectives and listens openly to others’ points of views
- Prior management experience preferred
- Proficient with electronic systems
- This position may require up to 5% of travel
- We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
- Compensation Overview:
- The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
- Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
- U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
- Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
- Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
- U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
- How We Work
- Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
- Supporting People with Disabilities
- BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
- Candidate Rights
- BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
- For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
- Data Protection
- We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
- Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
- If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
About Bristol Myers Squibb
Pharmaceutical Manufacturing32654 employeesFounded 1887
Transforming patients' lives through science.
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