Associate Director -GRS CMC cell therapy
Role Overview
• 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 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.
• The GRS-CMC Associate Director will lead a team of CMC regulatory professionals, setting priorities and overseeing the quality and timeliness of the team’s CMC submissions across multiple development and life-cycle management projects of varying priorities and complexities.
• The Associate Director supports the growth and development of team members, represents GRS-CMC on cross-functional teams, serves as a credible, respected spokesperson in discussions with key stakeholders, and seeks opportunities for external regulatory engagement for themselves and members of their team.
• The GRS-CMC Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support BMS products 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 Associate Director will serve as the primary interface between Global Regulatory Sciences (GRS) and Cell Therapy Development Operations (CTDO). The GRS-CMC Associate Director will assess manufacturing change controls for global impact and guide technical teams on practical aspects of global change management.
Full Job Posting
Qualifications
- Minimum BA/BS Degree
- 8+ years Pharmaceutical industry experience – prefer knowledge of biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy
- Prior people management or team leadership experience preferred; experience coaching, mentoring, and developing team members
- Knowledge of CMC regulatory requirements for advanced therapies, biologics, and cell therapy during development and post-approval as applicable
- Knowledge of pharmaceutical development, including advanced therapies, biologic, and cell therapy upstream and downstream processes, analytical methods, and biologic/device combination, cell therapy products as applicable
- Expertise in the biological and cell therapy modalities, drug development process and analytical methods, preferred as applicable
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes
- Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
- Experience communicating regulatory strategy, issues, and risks, in written and verbal format, to regulatory senior leadership and other governing bodies
- Experience supporting health authority interactions on CMC topics and resolving CMC issues with regulatory authorities; ability to break down complex scientific content into logical components
- Seeks multiple perspectives and listens openly to others’ points of view
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to details
- Demonstrates ownership of results within (and beyond) area of responsibility
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved
- Looks for opportunities for continuous improvement
- Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals
- Communicates opinions, facts and thoughts with clarity, transparency, and honesty
- Experience applying project management techniques within teams. Experience in effectively managing meetings
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
- Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate
- Demonstrated ability to coordinate global activities
- 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
- Strong oral and written skills
- 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.
- 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/
- For roles based in Washington state only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.
- 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.
- R1607716: Associate Director -GRS CMC cell therapy
Preferred Qualifications
- Prior people management or team leadership experience preferred; experience coaching, mentoring, and developing team members
- Expertise in the biological and cell therapy modalities, drug development process and analytical methods, preferred as applicable
About Bristol Myers Squibb
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