Sr Project Manager, Operational Site Readiness
vor 1 Monat
Bei 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 Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
**Fixed term contract**
**The OSD-LSLF Operational Site Readiness Senior Project Manager has the responsibility to manage various critical operational readiness activities for a future manufacturing facility, which aims to be a Center of Excellence for OSD drug product manufacturing for BMS Switzerland. In this role you will have the overall management responsibility for ensuring all operational related activities to support site readiness are developed, managed, followed and sustained for future technical transfer activities as well as routine Clinicals/Manufacturing operations.**:
**You will be expected to provide direction and guidance for all operational topics encountered as part of the overall project. Additionally, liaising between the project team and routine site Manufacturing Operations will be required as part of the role. During the qualification phase of the project the you will be responsible for ensuring all operational readiness activities are completed for the facility.**:
**Skills/Knowledge Required**
- 10 years of experience in a pharmaceutical technical field (operations, maintenance, validation, production systems, facilities and equipment) under quality systems or GMP compliance
- Strong leadership skills and has demonstrated previous successes as manager.
- Expert in Oral Solid Dosage (OSD) drug product manufacturing and commercialization, process engineering, and experience in continuous manufacturing operations would be an asset.
- Experience managing and leading diverse teams and interfacing with multiple stakeholders.
- Excellent communication and presentation skills.
- Understanding of project management systems and tools.
- Ability to work independently and to influence and work across organizational boundaries.
- Excellent command of English and preferably French language.
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face to face interaction and response to audit questions.
**Duties and Responsibilities**
- Collaborate with site function heads to map the future organizational design and build the recruitment strategy.
- Lead the review of the P3 layout with the Manufacturing team to ensure optimum flow of personnel and materials.
- Responsible for the operational readiness plan for site documentation update and creation (SOPs, work instructions and logbooks).
- In charge of the communication and change management, meaning developing and executing the Change Control strategy and approach to manage the people-side of change, to achieve the required project/program outcome.
- Work closely with the Jacobs Engineering firm, BMS Global Engineering and BI&A teams to build capacity modelization tools, which will help to plan production capacity, identify bottlenecks, size utilities, and perform simulation for potential future assets.
- Support authority approval of the new facility
- Create and collaborate with other workstreams to build a training program to get necessary technical skills and knowledge and to ensure compliance with cGMP requirements
- Ensure alignment with environmental monitoring program, calibration and maintenance program
- Provide expert operational readiness support and manage critical interfaces with key business stakeholders for program/project scope definition, design, commissioning, operator acceptance, and training.
- Track performance of operational readiness against defined milestones and report on progress, risks, resolution, and escalation of issues through governance channels where needed.
- Define and communicate operational readiness capability requirements to the business.
Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privat
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