Principal Scientist, Analytical Network Investigator
vor 2 Wochen
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.
**Reporting into the Analytical Network Compliance and Operations group, Global Quality Analytical Science and Technology, the Principal Scientist Analytical Network Investigator will be responsible for supporting the Analytical network by leading complex multidisciplinary, multi-site analytical and microbiological investigations, serving as the Subject Matter Expert for Root Cause Analysis within the internal global investigation network and to external partners, and coaching and mentoring scientists for Root Cause Analysis. In addition, this role has accountability for implementation of enterprise projects in GQAS&T.**:
Key Responsibilities
- Leads multiple CAPAs, investigations (including laboratory investigations), or proactive initiatives for complex, multidisciplinary, multi-site, analytical and microbiological Root Cause Analyses across the Analytical Quality Control network internal and external.
- Owns deviations as appropriate and supports the eventual Notification to Management process
- Serves as a Subject Matter Expert for Root Cause Analysis and Microbiology as requested to support network investigations. Represents the organization as a technical expert for projects and initiatives.
- Designs complex technical projects or investigations, interprets diverse data and/or results, and independently recommends next steps.
- Leverages Operational Excellence principles, Lean principles, and Quality Risk Management principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste across the enterprise.
- Regularly adapts standard Root Cause Analysis methods and techniques to unique investigations, using expertise to select the best-in-class approach.
- Recommends novel solutions and makes decisions that solve complex problems identified in investigations. Solutions improve the ability of a team to deliver on its objectives and meet the needs of stakeholders.
- Actively mentors others to facilitate growth of less experienced scientists within the team, across the network, and externally.
- interfaces with internal and external auditors during plant inspections as needed to support investigations.
- Works independently as a Lead Investigator, Subject Matter Expert for Root Cause Analysis, or Project Manager.
- Willingness to travel to support analytical internal and external network laboratories.
- Remains engaged with current industry standards, trends, and regulatory expectations by participating in training and industry conferences
- Manages multiple AS&T projects or programs, as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders.
- May oversee a small team of investigators
Qualifications & Experience
- Bachelor’s Degree required. Degree in Analytical Science, Microbiology, or closely related discipline. Master’s Degree preferred. Business degree a plus.
- Minimum 10 years of experience with Quality Control, Quality Assurance, Analytical Science, and/or Microbiology in a GMP manufacturing environment.
- Requires advanced knowledge of GMP and Compliance applicable to Quality Control, and thorough knowledge of Microbiology.
- Project Management certification preferred.
- Thorough knowledge of Lean principles and Operation Excellence principles a plus.
- Strong ability to communicate across levels and adapt communications to the audience.
- Highly proficient in technical writing, GMP procedures, formal reports/documents, technical presentations.
- Strong ability to think strategically, and to translate strategy into action.
- Strong ability to prioritize and provide clear direction to team members in a highly dynamic environment.
- Ability to provide support remotely while maintaining a high level of performance
- Safety
- Works in partnership with site EHS to ensure the group operations comply with environmental and safety regulatory standards.
- Maintains a safe work environment by ensuring that department personnel follow site EHS policies and procedures
- Work Environment Conditions
- This is primarily a day shift position. Off-shift support could be required to ensure production, projects, and network/site goals and objectives are met Minimum 10 years of experience with Quality Control, Quality Assurance, Analytical Science, and/or Microbiology in a GMP manufacturing environment.
- This position is located at the BMS site of Boudry Switzerland, wo
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