Scientist, Lead Investigator
Vor 4 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.
MS&T is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our OSD products and their processes. We work across the entire lifecycle of our pharmaceutical products, supporting Boudry manufacturing site.
The Lead Investigator is accountable for conducting deviation investigations until conclusion within the standard scrutiny of governing compliance bodies in support with the Global Investigation Program. Scope of investigations relates to all types of manufacturing processes, such as bulk production, packaging operations, warehousing and supply, technical services.
**Duties and Responsibilities**
The Lead Investigator’s main activities are completed autonomously for the following tasks and responsibilities:
- Facilitate triage of deviations in order to assist deviation owners to define need for investigations.
- Supports initial impact/risk assessment for all deviations in conjunction with Quality Operations.
- Lead and conduct investigations until conclusion and ensures that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective and compliance manner. Investigation scope may be related to bulk operations, packaging operations, warehouse, or maintenance processes.
- Partner with quality assurance and impacted departments (production, quality control, warehouse, maintenance, etc) to ensure investigations are exhaustive.
- Provide appropriate level of reporting and communication on the assigned investigations, at site and global levels (Investigation Review Board, pharma MS&T reporting)
- Share good practices within the site and with other sites.
- Perform complaint investigations.
- Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Participate to or lead projects and initiatives within Boudry MS&T team.
- Provide support to other MS&T teams (such as robustness, qualification,.) as required
**Skills/Knowledge Required**
- BS/MS in Engineering/Technical discipline or equivalent experience
- Experience in pharmaceutical operations, validation, packaging or related field, if possible Oral Solid Dosage manufacturing
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc) is a nice to have.
- Well-developed ability to constructively work across functional areas and levels to achieve results,
- Technical writing skills,
- Strong communication skills,
- Strong analytical, problem solving, influential and deductive skills,
- Capability to work with short deadlines and simultaneous activities,
- Excellent organizational and project management skills.
- Fluent in English and in French.
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.
-
Lead Investigator, Quality Control
vor 1 Tag
Boudry, Schweiz LHH VollzeitOur client, a global biopharmaceutical company based near Neuchatel, is looking for a Lead Investigator, Quality Control for a long-term mission. The Lead Investigator will join the QC Business Enabling and Support team of the Quality Control (QC) department. The QC department is responsible for testing raw materials, drug substance (API), drug product...
-
Clinical Scientist Team Lead
vor 11 Stunden
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...
-
Cllinical Scientist Program Lead
Vor 6 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...
-
Clinical Scientist Program Lead, Cellular Therapy
vor 12 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...
-
Sr Clinical Scientist
vor 1 Tag
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...
-
Clinical Scientist
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...
-
Clinical Scientist, Cell Therapy
vor 1 Tag
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...
-
Sr Clinical Scientist
vor 1 Tag
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...
-
Clinical Development Lead, RHeumatology
vor 12 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...
-
Scientist, Validation and Robustness
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...
-
Clinical Development Lead, Hematology
vor 1 Woche
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...
-
Clinical Development Lead-oncology
Vor 3 Tagen
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...
-
Principal Scientist
vor 12 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...
-
Clinical Trial Physician
vor 1 Woche
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...
-
Principal Scientist Packaging
vor 1 Tag
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...
-
Principal Scientist Stability
vor 12 Stunden
Boudry, Schweiz Interiman Vollzeit**INTRODUCTION**: For our client, a leading international Pharmaceutical company, we are searching for a: **Principal Scientist Stability - 100% - 12 months temporary contract** **English & French** This position is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug...
-
Director, Ww Medical Cell Therapy, Lymphoma
Vor 3 Tagen
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...
-
Director, Early Clinical Development
Vor 3 Tagen
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...
-
Assistant Scientist, Ms&t
vor 12 Stunden
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...
-
Assistant Scientist, Ms&t
vor 12 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...
