Job Information
Bristol Myers Squibb Executive Director, Cell Therapy Analytical Science and Technology in Devens, Massachusetts
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 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.
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.
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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Company: Bristol-Myers Squibb
Req Number: R1588330
Updated: 2024-12-29 03:30:20.127 UTC
Location: Devens-MA
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.