Scientist, Validation and Robustness
vor 1 Woche
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.
**Position Summary**
The Validation & Robustness Scientist is supporting the development and implementation of strategies that ensure Global Commercial Supply is maintained in a constant state of compliance for the good of our patients. More specifically, the Validation & Robustness Scientist partners with other MS&T functions to design and execute procedures that guarantee the manufacturing robustness at internal and external sites.
**Skills/Knowledge Required**
- Degree in Engineering, Chemistry, Pharmacy or Natural Science.
- Minimum 5 years of experience in pharmaceutical industry and in GMP validation activities are considered an asset but not mandatory.
- Ability to work well as part of a large Project Team.
- Ability to work across organizational boundaries.
- Good written and verbal communication and interpersonal skills.
- Good command of English and preferably another European language.
**Duties and Responsibilities**
- Lead/Support the implementation of structures, tools, and processes to actively manage process performance/robustness across the BMS Pharma portfolio.
- Contribute to ensure that new pharma products are launched with an appropriate level of robustness, in collaboration with other MS&T functions and Manufacturing site.
- Design and execute procedures that enable an efficient collection of data (possibly in real time) from the different unit operations in line with the defined control strategy.
- Perform analysis of data and draw up robustness boards.
- Lead the issuing of Continued Process Verification plans and reports.
- May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle
- Prepare protocols and reports that enable execution of experiments or Technical Batches.
- Lead / support the completion of investigations led by Boudry MS&T by issuing documents or reports.
- Interface with multiple sites and departments (i.e., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) and suppliers to accomplish predefined goals.
- Support the development of project plans for validation and qualification activities and ensure results are delivered in a timely manner.
- Author and when required review validation documents, including but not limited to validation plans, protocols, reports, traceability matrices and summary reports.
- Execute validations / qualifications for equipment and systems across the site
- Lead risk assessments and risk management teams
- Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
- Manage validation projects; including managing time, resources and budgets; own associated change controls
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments
- Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation
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.
-
Principal Scientist
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...
-
Principal Scientist Packaging
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...
-
Assistant Scientist, Ms&t
Vor 2 Tagen
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...
-
Sr 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...
-
Assistant Scientist, Ms&t
Vor 2 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 Exm
Vor 2 Tagen
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...
-
Scientist, Lead Investigator
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...
-
Principal Scientist Exm
Vor 2 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...
-
Cllinical Scientist Program 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...
-
Clinical Scientist Team Lead
Vor 2 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...
-
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...
-
Boudry, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Sr. Specialist Scientist QC Analytical Technical Support, BoudryClient: Bristol Myers SquibbLocation: BoudryJob Category: Customer ServiceJob Reference: 09a6cfa0cd73Job Views: 11Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that...
-
Packaging Validation Expert
Vor 6 Tagen
Boudry District, Schweiz Bristol Myers Squibb VollzeitBristol Myers Squibb is committed to hiring the best talent in the industry, and we are currently seeking a Packaging Validation Expert to join our team in Boudry, Switzerland. The successful candidate will be responsible for validating and verifying methods for packaging materials, both internally and externally with contract testing laboratories.The ideal...
-
Stagiaire en Validation
vor 23 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 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...
-
Compliance Officer, IT Systems Validation
Vor 2 Tagen
Boudry District, Schweiz Bristol-Myers Squibb SA VollzeitKey ResponsibilitiesLead and support a team of IT compliance experts.Responsible for supporting site IT systems compliance, ensuring these are maintained in accordance with regulatory requirements (EU-GMP Annex 11 & 21-CFR part 11) and Computerized System Validation (CSV) procedures.Establish a cross-functional network with the business to support...
-
Clinical Scientist
vor 2 Wochen
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
Vor 2 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...
-
Clinical Scientist
Vor 4 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...
-
Principal Scientist Stability
Vor 2 Tagen
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...
