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.

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. Read more: careers.bms.com/working-with-us.

Fixed Term Contract : 18 months

The Senior Scientist, Validation & Robustness, is responsible for managing process related qualification/validation activities through the complete validation life cycle. 

Primary responsibilities include:

• Equipment Qualification,
• Process Performance Qualification,

Serves as a Subject Matter Expert in a specific Process Validation specialty and provides expert technical recommendations / guidance. Leads med scale projects, prepares and leads project schedules / project teams, executes validation studies / investigations, and performs associated data analysis applying the principles of statistics and quality risk management.

Your main responsibilities are:

• Independently performs in Validation, document generation, management, and execution activities.
• Interface with engineering, validation, and end user groups as a subject matter expert to provide technical guidance with validation including but not limited to production equipment. 
• Design the validation/qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation/qualification protocols.
• Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing. 
• Lead projects, prepare project schedules and execute validation studies, perform complex data analysis, and write protocol summaries, reports, and technical reports.
• Support or/and lead investigations associated with qualification activities.
• Own and execute projects, programs, procedures, investigations, and activities.
• Manage projects in the work group and lead specific project teams (and multiple projects), coordinate the execution of validation projects, prepare project schedules and provide presentations to senior management / stakeholders on project status. 
• Manage timelines, resources, and communications specific to individual tasks.
• Execute CAPA plans, risk programs and assessments, investigations, and root cause analysis.
• Intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
• Write and process change controls, assess impact to validated equipment.
• Train and mentor less experienced department personnel.
• Performs general administrative and organizational activities.
• Complete regulatory, site, and department training requirements on a timely basis.
• Performs other tasks as assigned.

Qualifications & Experience

• Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science.
• Minimum 4-6 years of experience in pharmaceutical industry with MSc degree or 7-9 years’ experience with BSc and in GMP validation activities are considered an asset
• Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework.
• Good knowledge of current validation practices and experience of fronting regulatory inspections.
• The ability to influence and work across organizational boundaries.
• Good command of English and preferably another European language Strong written and verbal communication and interpersonal skills
• Project and change management experience. Experience with Product Life Cycle Management. 
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
• Self-starter, team player, effective leader and keen on working in a cross-cultural working environment.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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