Bristol-Myers Squibb
Executive Director, Cell Therapy Analytical Science and Technology
Bristol-Myers Squibb, Summit, New Jersey, us, 07902
Executive Director, Cell Therapy Analytical Science and Technology
Apply locations: Summit West - NJ - US, Princeton - NJ - US, Devens - MA - US, Seattle - WA - US, New Brunswick - NJ - US Time type: Full time Posted on: Posted 13 Days Ago 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. POSITION SUMMARY: The Executive Director, Cell Therapy Quality Analytical Science & Technology (ED, CTQ, AST) is accountable for delivering commercially robust and globally compliant analytical strategies and outcomes that sustain the product supply chain throughout the product lifecycle. Accountable for cell therapy analytical method validation and transfer, including highly complex bioanalytical methods, analytical CMC strategy, stability program, and end-to-end life-cycle management for cell therapy. The scope of the role includes cell therapy cell banks, plasmids, viral vectors, drug product intermediates, drug products, and finished labeled drug product. The Executive Director, Cell Therapy Quality, Analytical Science & Technology (ED, CTQ, AST), in the nascent field of cell therapy, is skilled at development of analytical strategy including strategies for complex early generation bio-assay methods with limited industry guidance. The ED, CTQ, AST is a motivated, engaged, solutions-driven, and adaptable leader who supports the VP of Cell Therapy Quality, the senior Cell Therapy Leadership Team, in the advancement of analytical readiness for Cell Therapy at BMS. The ED, CTQ, AST is a strategic leader, operational integrator, and implementer to ensure that analytical strategies and methods are commercially ready across the Cell Therapy landscape, as well as direct management of operational responsibilities including CT global stability programs, QC readiness, reference standard support, and analytical leadership for the CT GO teams. RESPONSIBILITIES: Lead the Cell Therapy Analytical Science & Technology team for BMS Cell Therapy franchise. Ensure the methods used to release product and support shelf life are suitable for their intended use, robust, and globally compliant. Cell Therapy AST partners and collaborates with Cell Therapy Operations and Cell Therapy Development to troubleshoot and triage methods to minimize or eliminate the impact of test methods on the global supply chain. Partner across development, operations, and regulatory to define and deliver analytical control strategies (methods and specs) that comply with internal and external quality standards and regulatory requirements. Develops and improves analytical method control strategies for cell banks, plasmids, viral vectors, drug product intermediates, drug products, and finished labeled drug product. Oversees generation and review of data (i.e., market life stability programs, periodic review of methods, etc.) used to determine continued suitability of drug supply throughout the product lifecycle. Ensures that clinical and commercial analytical strategies and outcomes comply with internal and external directives/policies/procedures and for assurance that product quality is maintained through the testing and release process. Supports clinical and commercial global regulatory filings and authors/reviews/approves portions of the filings related to method development, qualification, and/or validation as required. Provides quality oversight of analytical method strategies in support of development, characterization, and comparability studies conducted in collaboration with process development, manufacturing sciences and technologies, analytical development, quality control, and/or stability. Excels at analyzing complex data, information and issues, assessing risk, designing appropriate strategies and overseeing execution of the strategies through completion. QUALIFICATIONS: Specific Knowledge, Skills, Abilities, etc: Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical analytical development lifecycle are required. Demonstrated decision-making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements are required. Experience in Cell Therapy (preferred), Biologics and Sterile manufacturing or technical support. Proven track record of delivering the analytics and associated analytical CMC strategies for late-stage and commercial cell therapy products. Experience implementing quality strategy and standards related to analytics. Direct experience managing interactions with global regulatory agencies and in the preparation of regulatory submissions. Demonstrated ability to develop technical and strategic leadership talent to meet current and future business needs. Experience leading a large, diverse, geographically dispersed group of colleagues. Ability to build strong, trusting relationships, lead large/complex teams, and work across divisions, diverse business backgrounds, and cultures. Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization. Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders from both Cell Therapy Development and Operations and Global Product Development & Supply in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the VP of Cell Therapy Quality to interface with stakeholders in a matrix environment. Has a proven track record of delivering results and is action-oriented. Education/Experience/Licenses/Certifications: Advanced degree in life sciences or related discipline preferred. Minimum of 15 years of biopharmaceutical and/or quality experience in both R&D and commercial manufacturing environments.
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Apply locations: Summit West - NJ - US, Princeton - NJ - US, Devens - MA - US, Seattle - WA - US, New Brunswick - NJ - US Time type: Full time Posted on: Posted 13 Days Ago 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. POSITION SUMMARY: The Executive Director, Cell Therapy Quality Analytical Science & Technology (ED, CTQ, AST) is accountable for delivering commercially robust and globally compliant analytical strategies and outcomes that sustain the product supply chain throughout the product lifecycle. Accountable for cell therapy analytical method validation and transfer, including highly complex bioanalytical methods, analytical CMC strategy, stability program, and end-to-end life-cycle management for cell therapy. The scope of the role includes cell therapy cell banks, plasmids, viral vectors, drug product intermediates, drug products, and finished labeled drug product. The Executive Director, Cell Therapy Quality, Analytical Science & Technology (ED, CTQ, AST), in the nascent field of cell therapy, is skilled at development of analytical strategy including strategies for complex early generation bio-assay methods with limited industry guidance. The ED, CTQ, AST is a motivated, engaged, solutions-driven, and adaptable leader who supports the VP of Cell Therapy Quality, the senior Cell Therapy Leadership Team, in the advancement of analytical readiness for Cell Therapy at BMS. The ED, CTQ, AST is a strategic leader, operational integrator, and implementer to ensure that analytical strategies and methods are commercially ready across the Cell Therapy landscape, as well as direct management of operational responsibilities including CT global stability programs, QC readiness, reference standard support, and analytical leadership for the CT GO teams. RESPONSIBILITIES: Lead the Cell Therapy Analytical Science & Technology team for BMS Cell Therapy franchise. Ensure the methods used to release product and support shelf life are suitable for their intended use, robust, and globally compliant. Cell Therapy AST partners and collaborates with Cell Therapy Operations and Cell Therapy Development to troubleshoot and triage methods to minimize or eliminate the impact of test methods on the global supply chain. Partner across development, operations, and regulatory to define and deliver analytical control strategies (methods and specs) that comply with internal and external quality standards and regulatory requirements. Develops and improves analytical method control strategies for cell banks, plasmids, viral vectors, drug product intermediates, drug products, and finished labeled drug product. Oversees generation and review of data (i.e., market life stability programs, periodic review of methods, etc.) used to determine continued suitability of drug supply throughout the product lifecycle. Ensures that clinical and commercial analytical strategies and outcomes comply with internal and external directives/policies/procedures and for assurance that product quality is maintained through the testing and release process. Supports clinical and commercial global regulatory filings and authors/reviews/approves portions of the filings related to method development, qualification, and/or validation as required. Provides quality oversight of analytical method strategies in support of development, characterization, and comparability studies conducted in collaboration with process development, manufacturing sciences and technologies, analytical development, quality control, and/or stability. Excels at analyzing complex data, information and issues, assessing risk, designing appropriate strategies and overseeing execution of the strategies through completion. QUALIFICATIONS: Specific Knowledge, Skills, Abilities, etc: Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical analytical development lifecycle are required. Demonstrated decision-making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements are required. Experience in Cell Therapy (preferred), Biologics and Sterile manufacturing or technical support. Proven track record of delivering the analytics and associated analytical CMC strategies for late-stage and commercial cell therapy products. Experience implementing quality strategy and standards related to analytics. Direct experience managing interactions with global regulatory agencies and in the preparation of regulatory submissions. Demonstrated ability to develop technical and strategic leadership talent to meet current and future business needs. Experience leading a large, diverse, geographically dispersed group of colleagues. Ability to build strong, trusting relationships, lead large/complex teams, and work across divisions, diverse business backgrounds, and cultures. Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization. Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders from both Cell Therapy Development and Operations and Global Product Development & Supply in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the VP of Cell Therapy Quality to interface with stakeholders in a matrix environment. Has a proven track record of delivering results and is action-oriented. Education/Experience/Licenses/Certifications: Advanced degree in life sciences or related discipline preferred. Minimum of 15 years of biopharmaceutical and/or quality experience in both R&D and commercial manufacturing environments.
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