Scientist, Lead Investigator

☞ Bristol Myers Squibb

View: 169

Update day: 29-03-2024

Location: Boudry Neuchâtel NE

Category: R & D IT - Software

Industry: Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

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 ResponsibilitiesThe 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.
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Deadline: 13-05-2024

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