Associate Director, Analytical Services External Relationship Manager - Cell Therapy

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The External Relationship Manager (ERM) is accountable for overall relationship management and operational oversight of one or more contract test labs (CTLs) performing analytical services used in delivery of cell therapy gene delivery and editing materials (e.g., viral vector) and drug product manufactured within the external cell therapy manufacturing network. The global scope includes contract analytical labs and alliance partners supporting both clinical and commercial material delivery. A primary focus is leadership of virtual analytical teams (VATs), which interface closely with the BMS external manufacturing network and internal stakeholders, to ensure delivery of quality test results with speed, agility and flexibility to support the clinical and commercial supply chains. The ERM is accountable for the performance of the virtual analytical teams and CTLs under her/his responsibility.

The ERM is a leader with the breadth of professional experience and the drive to work with both internal stakeholders and CROs to define and implement cell therapy analytical test strategies and plans. She / he is responsible for partnering with Strategic Sourcing & Procurement to ensure that the right network partners are identified at the right time and managed to assure robust delivery of analytical services and data.

The ERM must have proven experience in implementation of strategic initiatives in a dynamic business environment, a solid technical operational background, and understand the challenges and impact of identifying, selecting, and managing partners. She / he must be able to adapt to risks/changes associated with highly novel technologies and distill trade-off decisions into recommendations for escalation to leadership/negotiation with CROs, to meet the BMS program objectives.

Acting as the relationship manager and the primary point of contact with the CTL management, the ERM is ultimately responsible for the CT performance and for successful execution of the analytical services operations at the CRO site(s). The ERM is a leader with a demonstrated track record of success in a highly matrixed and cross-functional organization, with a high level of independence and empowerment to deliver against strategic program goals.

The ERM may serve as Cell Therapy External Manufacturing’s representative for development of analytical strategies, interacting with key stakeholders across the cell therapy enterprise. In this role, the ERM is responsible for interacting with functional project leaders, GO-CT and CMC leaders, external manufacturing colleagues, and other stakeholders in development of strategies that impact external analytical services.

Key job responsibilities:

• Responsible for overall vendor governance for CTLs within remit. Develops and maintains strong strategic relationships with the CTLs to ensure the best outcomes for BMS cell therapy assets, both short and long-term. Partners with CTLs to provide operational and project execution oversight for analytical programs.
• Leads virtual analytical matrix teams, where cross-functional team members are accountable for prioritization and execution of external analytical test operations and plans.
• Assures delivery of analytical test results supporting clinical and commercial supply that meets quality, compliance, schedule and budget expectations through proactive identification and mitigation of risks. Includes management of performance expectations and business critical issue escalation.
• Partners closely with internal and external stakeholders to define and implement KPIs that provide meaningful data to support Quality Agreements, master service agreements, SOWs and performance against BMS and CTL expectations. Monitors trends and KPIs in a manner that provides high visibility to program deliverables -sample testing status dashboards, timelines, program risk (high-impact issues, sample trending and KPIs), resource utilization & turnaround time. Supports Global Quality in management of CTL quality events, deviations, and change controls.
• Partners closely with Cell Therapy Quality, Cell Therapy Development, Strategic Sourcing & Procurement, & Global Manufacturing Science & Technology to implement sustainable continuous improvement plans and analytical strategies at CTLs. Utilizes OpEx strategies to support programs and to ensure an on-going culture of continuous improvement and alignment across the BMS global outsourcing analytical network.
• Partners closely with Strategic Sourcing & Procurement throughout all phases of the vendor selection process. Provide business insight for negotiation and execution of contractual documents focus on creating the agility, flexibility, and risk-sharing frameworks to support the fluidity associated with novel technologies. Acts as contract monitor for existing agreements.
• Partners with CTLs and internal stakeholders to draft, manage, and deliver on annual performance targets, and operating budget. Manages the annual budget for the CTLs under her / his responsibility.
• Partners with other relationship managers across Global Product Development & Supply in a community of practice to share best practices, learnings and other information important to continuous improvement of CTL and CDMO management processes and tools.
• Partners with internal stakeholders and CROs to support business continuity and third- party risk management programs.
• Live the BMS values

Required Qualifications and Experience

• BS degree in relevant scientific discipline, advanced degree a plus
• >7 years of experience in the pharmaceutical industry with at least > 3 years of experience in an analytical leadership or QC role. Experience in biologics and/or cell therapy analytical science, assay, and validation practices a plus.
• > 3 years of experience in an external facing role.
• Knowledge of GLPs, GMP, E.P./J.P./USP compendia, 21 CFR Part 11, and FDA/EMEA analytical and bioanalytical guidances preferred.
• Demonstrated ability to deliver outstanding results through leadership of matrix teams and to work effectively with cross-functional and multi-location teams. Experience working in and with multiple geographies a plus.
• Ability to establish strong relationships and achieve success through collaboration.
• Ability to solve complex problems with innovative solutions. Strong critical thinking skills.
• Able to effectively transfer complex knowledge regarding science and analytical procedures.
• Ability to expresses one’s-self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience
• Ability to travel on an as-needed basis

BMSCART #LI-Hybrid VETERAN

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.