Scientist, Lead Investigator

**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 the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Fixed Term Contract : 8 months**

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. The scope of investigations relates to all types of manufacturing processes, such as bulk production, packaging operations, warehousing and supply, technical services.

**Duties/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.

**Qualifications**

Education/Experience/ Licenses/Certifications:

- 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.

Specific Knowledge, Skills, Abilities:

- 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.

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.