Job Information
Bristol Myers Squibb Senior Manager, Operation Manager in Chiyoda, Japan
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 .
Position Summary
The primary focus of the External Manufacturing Production Manager, Cell Therapy role is to oversee cell therapy manufacturing activities at specific BMS’s Contract Manufacturing Organizations (CMOs) and to implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of concerned products. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional impact. The successful candidate should have a strong operational, quality, compliance, and technical background, with proven project management and supplier management abilities. The candidate will be requested to travel to the CMO’s site for potentially frequent and / or extended periods of time with a requirement to occasionally travel elsewhere as needed. The successful candidate will be a key member of the Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.
Duties/Responsibilities
The key deliverables for this role are to ensure reliable supply of external manufacturing operations through:
General and team
o Responsible for operational aspects of CMO management, ensuring compliant, efficient, and timely production and delivery of products
o Ensures smooth execution of manufacturing-related projects and process improvements, acting as a resource for CMO stakeholders on their requests to BMS stakeholders and vice versa
o Function as a key point of contact for all BMS interests/activities at Contract Manufacturing Organizations (CMOs)
o Support the Supplier Relationship Manager in building and maintaining mutually beneficial relationships with the CMO organization(s) in scope, as well as with key internal stakeholders, developing a partnership approach
o Live and support deployment of the BMS values
Production
o Provide operational oversight of CMOs to ensure all deliverables meet or exceed BMS requirements. This includes but is not limited to negotiating manufacturing slots aligned with BMS’s needs, ensuring compliant and timely
manufacturing, on-time / in-full (OTIF) shipments, quality compliance and cost management, ensuring proper approval and execution of change control and lifecycle management initiatives, supporting the resolution of deviations etc.
Be the BMS ‘eyes and ears’ at the CMO for flawless execution of commercial operations
o Leverage BMS VPT stakeholders to provide guidance to CMOs and ensure cross-functional alignment on priorities and deliverables
o Lead change management, issue resolution and adherence to agreed deliverables.
o Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
o Compiles key performance indicator reports.
o Coordinate the preparation of governance meetings and management reviews
o In close relation with CMO and BMS VPT stakeholders, lead, prioritize and track efficient execution and documentation of key activities to meet BMS requirements. This includes, but is not limited to initiation, execution, tracking and
closure of change controls, investigations, and deviations.
o Identify, escalate, and participate in the resolution of business-critical issues effecting Compliance, Operations and Management
o Participate in regular staff and governance meetings to agree on priorities and tactics
Project management
o Manage a portfolio of multiple cross-functional external manufacturing projects, with a focus on developing and maintaining overall project plan objectives and timelines
o Collaborate with CMO and internal stakeholders to understand planned changes, set priorities, define required budget and resources, and manage the end-to-end implementation process including but not limited to change controls and
impact assessments. Effectively communicate status and expectations internally and to CMO. Escalate as needed.
o Support product, technical and business process lifecycle management activities
o Maintain action trackers, SharePoint Forms and Risk Registers.
o Lead or support other CMO- or Virtual Plant Team (VPT)-related projects
Performance and continuous improvement
o Act as the key liaison to facilitate post-campaign / periodical (as applicable) and CAPA effectiveness review at CMOs
o Establish a robust tracking and reporting process to ensure compliance with internal/external audit observation deadlines or other regulatory commitments.
o Facilitate collation of data to track CMO and VPT performance and compliance on metrics including but not limited to adherence to contractual agreements such as on-time-in-full (OTIF) delivery and release, spend/budget,
product quality and supply integrity
o Facilitate process improvement initiatives with CMO, VPT and supporting business processes
o Track and ensure compliant and timely execution and closure of responses to audit and inspection observations or of other regulatory commitments
o Create and maintain process maps and tools, maintain related SOPs and work instructions up to date, in collaboration with other VPT representatives.
o Collaborate with other VPTs to exchange experience and best practices
o Support root cause analysis and risk assessments
o Support budget management and tracking, initiate project and change orders, track invoices and forecast CMO spend.
Reporting Relationship
Works in close collaboration with the Supplier Relationship Manager in charge of the overall relation with the CMO, and reports to the Executive Director, Cell Processing and drug product External Manufacturing.
Qualifications
Bachelor’s degree required, ideally in cell biology, biotechnology, biochemistry, or closely related disciplines
Minimum 5, preferably 7 years of experience working in cell therapy or biopharmaceutical manufacturing, quality, Manufacturing Science and Technology, Supply Chain, or biopharmaceutical development
Strong quality and compliance background in a commercial and/or clinical GMP operational environment; sound working knowledge of health authority regulations
Technical background in aseptic operations is a plus
Solid project management skills and experience managing complex projects
Ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audienceboth in English and Japanese.
Strong leadership and ability to collaborate and build relationships is critical
Ability to work calmly and make sound decisions in an environment of uncertainty and change, including when facing technical, manufacturing- or supply-related issues .
Flexibility to work shift hours may occasionally be required to cover critical process steps
Ability to frequently travel, mainly to the CMO(s) under responsibility, is required
Travel: This position requires up to 25% of travel
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
BMS has a diverse 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.
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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1576845
Updated: 2024-04-26 01:25:12.003 UTC
Location: Chiyoda-ku-JPN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.