Sr Director, Japan External Supply Head

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“We do not accept any introductions or applications from external recruitment agencies.”

Position summary:

The head of Japan cell therapy external supply is accountable for global delivery of clinical and commercial products manufactured by contract development and manufacturing organizations (CDMOs) located in Japan.

This includes upstream (manufacturing intermediate) cell processing operations for several clinical and commercial products and downstream (finished drug product) cell processing operations for a major commercial product.

Leading a multidisciplinary and cross-functional matrix team, the role is accountable for strategic partnership management to implement, achieve and maintain reliable supply and performance within the external network.

The role partners closely across Cell Therapy Development and Operations to ensure setup, maintenance and expansion of required manufacturing capacity while meeting all safety, quality and service level standards as agreed with the business, as part of products life cycle management.

It is accountable for ensuring reliable and quality-compliant supply for the concerned products and markets, while supporting business needs through the appropriate balance of flexibility and manufacturing optimization.

It supports BMS’s clinical and commercial geographical expansion in the Asia Pacific (APAC) region by developing manufacturing capabilities aligned with the Franchise’s geographical strategy.

When needed, she/he leads technology transfers up to and including clinical and commercial readiness.

Accountable for > $100M of spend, driving financial stewardship and sustainable cost reduction without compromising safety, quality or supply is a key challenge to be met.

The role is the manufacturing relationship owner for the alliance partners for assets in scope and is highly matrixed. Assets in scope include all current commercial and pivotal cell therapy assets supplied in Asia Pacific including Japan.

Duties and responsibilities:

• Leads the cross-functional virtual plant team managing Cell Therapy manufacturing activities in Japan. This includes clinical and commercial products, with partial or complete production processes in scope.
• For activities in scope, ensures compliance with all applicable safety, regulatory and quality regulations and related BMS policies.
• Continuously maintains inspection readiness status for all geographies for which production is being performed (Japan and select Asia Pacific countries).
• Leads continuous improvement for all aspects related to manufacturing activities in scope, including Safety, quality, manufacturing and supply reliability, process robustness, capacity, and cost improvement.
• Partners across Cell Therapy Development and Operations (CTDO) to align long- and short-term production capacity with business needs, balancing flexibility and cost. In particular, represents manufacturing site(s) in scope at Sales / Development and Operation Planning and other applicable Supply Chain forums. Ensures compliance with applicable Supply Chain processes and contributes to their continuous improvement.
• Partners with Commercial organizations in applicable geographies to understand and adapt to their needs and constraints, and to communicate and educate about manufacturing needs and constraints. Develops the corresponding Supply Plan.
• Leads and manages the relationship with applicable CDMO(s). Accountable for contract negotiation, execution and monitoring, in collaboration with Global Procurement.
• Support establishment of strong, positive, engaged CDMO culture – including focus on safety, engagement, and patient mission focus.
• Aligned with BMS’s objectives and in collaboration with applicable functions such as Quality. Supply Chain and Technical Operations, defines the annual operational and investment budget. Monitoring and anticipating spend, the role is responsible for compliance with, and reporting of the approved budget.
• Ensures integration of the various business processes and deliverables, including but not limited to the IT infrastructure and interfaces with other functions and manufacturing sites as applicable for the products concerned.
• Achieves on-time technical deliverables and regulatory milestones with high quality technical and operational deliverables in all required geographies, to ensure success of projects while respecting timelines and budget.
• Remove obstacles, create options and escalate as appropriate to drive program milestones within timeline and budget.
• Represents CDMO(s) in scope at the applicable governance and tier meetings.
• Ensures collaboration with other internal and external sites to enable a network approach and to promote a community of practice, exchanging information about issues and improvement opportunities, and promoting continuous improvement.
• Ensures that the cross-functional virtual plan team members are and remain appropriately trained to the manufacturing and business processes, following the evolution of technology and of BMS’s and Industry’s practices.
• Owning cross-functional integrated project plans, the role is accountable for technology and process transfers as needed. It ensures clinical and commercial launch readiness, on time and on budget.

Reporting Relationship

This position reports to the VP of Cell Therapy External Manufacturing Cell Processing.

It manages a team of 5 to 10 reports and leads a cross-functional matrix team of 15 to 30 employees.

Qualifications/Requirements

• Consistently demonstrates BMS leadership expectations and Values
• Ability to lead complex projects involving multiple parallel and interdependent workstreams as well as new technologies in a moving environment.
• Strong technical expertise with biologics or cell therapy commercial manufacturing processes, technology transfer and/or start-up phase experience highly desired.
• Exposure to some of the major medicinal products regulatory agencies (PMDA, TGA (plus), FDA, EMA etc.).
• Proven ability to effectively and independently manage and influence a diverse stakeholder group including senior leaders within BMS, and to negotiate with senior external stakeholders at CDMOs.
• Demonstrated portfolio management competency.
• Ability to comprehend complex and demanding supply chain environments, including high production volumes, strong focus on patient and timelines etc., in an international environment (US, Europe, Asia-Pacific / Japan).
• Demonstrated success in developing and organizing business processes, key metrics, scorecards, and dashboards.
• Demonstrated ability to lead people and cross-functional and multi-location teams in a matrix, complex and dynamic environment.
• Demonstrated ability to work independently in a fast moving and increasingly complex environment with limited direction.
• Ability to establish strong relationships and achieve success through collaboration and influence.
• Demonstrated strong negotiation and persuasion skills, dealing with conflict and ambiguity, and presenting to and managing senior stakeholders.
• Expertise of sourcing methodology and vendor selection.
• Demonstrated success negotiating complex supply and toll manufacturing agreements with CDMOs.
• Business and financial savviness.
• Strong written and verbal communication skills, including presentation to senior executive leadership.
• Experience of a culturally diverse workplace through international projects or global teams, and to deal with international customers and supply chain.
• This position requires up to 20% of travel.
• Japanese/English required for role based in Japan

“We do not accept any introductions or applications from external recruitment agencies.”

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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/

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R1600699 : Sr Director, Japan External Supply Head