Associate Director
Vor 6 Tagen
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 **Associate Director** - **Global Quality Analytical Science and Technology / Method Lifecycle** is responsible for managing a global team of analytical chemists that provides lifecycle management of the commercial testing methods supporting the BMS pharma (small molecule) portfolio. The incumbent provides expertise and guidance to problem-solving efforts at BMS and third-party manufacturing and testing sites, including laboratory investigations and troubleshooting QC & operational issues. The team performs analytical method remediation, validations/verifications, implementation, and transfer of analytical procedures according to the BMS Quality System. Additional aspects of lifecycle management include, (1) working with MST on continuous improvement initiatives; (2) working with CMC for ROW expansion and ensuring Regulatory expectations are met and up to date; and (3) participating in monitoring method performance by tracking strategic parameters throughout the lifecycle of the method. The Associate Director will provide critical input to technical documents and regulatory filings/responses. In collaboration, with development teams, the method lifecycle team ensures methods are fit for purpose in commercial QC environment and participates in new product introductions at commercialization sites
**Responsibilities**:
- The Associate Director is the SME for executing the overall scientific, technical, and operational efforts of pharmaceutical method lifecycle group. Group responsibilities include delivery of analytical methods needed to meet project milestones and product launches throughout the world, as well as associated regulatory and international requirements. The Associate Director and group provides SME leadership to BMS and external QC labs with method troubleshooting and laboratory investigation
- Management and development of a global team of experienced analytical chemists
- Participate in cross-functional teams as the analytical SME
- Collaborate with development teams to ensure methods are robust and appropriate for a QC commercial laboratory
- Manage and oversee the technical transfer of analytical methods to BMS and external testing labs, including new product introductions at commercialization sites. Review and approve technical documents (e.g., protocols and reports)
- Review and approve protocols and reports for analytical method validation/qualification
- Review method validation documentation to determine compliance with current ICH requirements and manage remediation of gaps as part of Periodic Method Review program
- SME for bridging studies between new and existing methods, method comparability studies and product comparability studies required to support CMC changes
- Support BMS Global Stability department on all analytical method related matters, including technical transfer, method support and laboratory investigations
- Responsible for analytical method change controls within the company Quality Management System and to ensure all required test data and reports are available to support and justify the change
- Review of change controls for impact to analytical methods and method validation status based on changes to manufacturing process or materials, compendial monographs/ chapters. Specification changes and other reasons
- Prepare /review and serve as SME for global and departmental procedures such as Policies, SOPs, and work instructions
- Executes on department goals and performance objectives, supports personnel development and addresses performance issues
- Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
- Influences and impacts others through building and maintaining strong networks that are leveraged to obtain critical information and accomplish objectives
- Recognizes and assists in resolving broad based complex issues across organizational boundaries
**Education**
BS in science with at least 15 years; or MS in science with at least 14 years; or Ph.D. with at least 12 years of relevant pharmaceutical experience
**Experience/Knowledge**
- Demonstrated ability to lead and develop people
- Thorough knowledge of cGMP/GLPs in the pharmaceutical industry, as well as technical expertise as it relates to filing and pharmacopeias requirements
- Understanding of the regulatory requirements in CMC development
- Overall awareness of the pharmaceutical manufacturing and quality processes and regulatory requirements necessary for the manufacture and di
-
Associate Director, Strategic Partnerships
Vor 3 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Associate Director, Biostatistics
Vor 7 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Associate Director, Biostatistics
Vor 3 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Associate Director, Worldwide Pricing Strategy
Vor 5 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Associate Director, Project Management
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director, Molecule Lead
Vor 7 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Associate Director Therapeutic Area Quality
vor 7 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitBei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...
-
Associate Director, Supply Chain Analytics
vor 7 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Associate Director, Drug Development Project
vor 7 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Associate Director Therapeutic Area Quality
vor 7 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Associate Director Biostatistics in Car-t
vor 2 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director, Worldwide Medical
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Market Access/heor Gbds Associate Director
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Market Access/heor Gbds Associate Director
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Performance and Insights Associate Director
vor 7 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Associate Director, Ww Medical Affairs, Multiple
vor 13 Stunden
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Associate Director, Clinical Pharmacology
Vor 7 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Associate Director, Worldwide Medical Immunology
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director, Worldwide Medical Hematology
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director, Worldwide Medical Oncology
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
