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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 .

The Sr. Specialist Scientist is part of the QC Analytical Technical Support (ATS) team of the Quality Control (QC) department of Celgene/BMS in Boudry, Switzerland. The Sr. Specialist Scientist acts as Business Owner for assigned QC Equipment and Computerized Systems. This role is responsible for leading equipment/systems acquisition and decommissioning activities. Provides subject matter expertise on qualification of new equipment and troubleshooting of analytical and equipment issues. This position supports the introduction of new products to the QC laboratories and owns equipment and/or systems related deviations. Additional responsibilities include performing super user activities for the laboratory computerized systems, representing QC in cross-functional meetings (e.g. multi sites system introduction/enhancement project) and participating in internal and external audits as Subject Matter Expert (SME). The Sr. Specialist Scientist will report to the Sr. Manager QC Analytical Tech Support.

Key Responsibilities

Business Owner of assigned QC Computer Systems.  

• Accountable to ensure that a computer system is fit for intended use in accordance with business requirements and applicable procedures throughout the system lifecycle.

• May act as a backup for other Business Owners within the QC ATS team.  

Super user of laboratory computerized systems:

• Administers user profiles and access to the systems.

• Defines requirements and performs audit trail reviews, assures adherence to data integrity principles.

• Authors instrument/system operating procedures.

• Is accountable for verification of custom calculations setup in QC software and used for analytical testing purposes.

• Performs master data management activities in QC computerized systems

• May perform and sign impact assessment of master data change requests as delegate of QC Management

Equipment and Computerized Systems Lifecycle Management

• Leads activities for acquisition, qualification, upgrade and decommissioning of analytical equipment and computerized systems.

• Develop Business Case to justify needs for new equipment.

• Works cross-functionally with the Analytical Development, Network QC, Local QC, IT, Validation Technical Services and Metrology to select, purchase, and qualify new analytical equipment for the QC laboratories.

• Owns and leads change controls.

• Leads or supports risk assessments.

• Authors, reviews, and approves validation documents as SME or System Owner and may also do so as delegate of QC Management.

• Owns and authors system operating procedures and other GMP documents. 

• Performs feasibility experimental work as needed.

• Collaborates with Metrology, Maintenance and Procurement to define requirements and contracts for the periodic maintenance and requalification of the equipment.

Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory.

• Owns deviations.

• Leads or supports investigations.

• Defines corrective and preventive actions (CAPA) and Effectiveness Checks.

Promotes safe practices and behaviors.

• Reports immediately incidents to Environmental Health and Safety department, participate in investigations and identify measures to prevent similar accidents in the future.

• Demonstrate Bristol Myers Squibb values.

Qualifications & Experience

Education and Experience

• BS degree in Life Science, Chemistry, or relevant scientific discipline or equivalent combination of education, training, and experience.

• Minimum 5 years relevant work experience required, preferable in a regulated pharmaceutical environment.

• Scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).

• Previous experience of laboratory equipment qualification is preferable.

Required Competencies: Knowledge, Skills, and Abilities

• Excellent scientific knowledge of chromatography techniques (HPLC, UPLC, GC), dissolution, Karl Fischer, and spectroscopic techniques.

• Good knowledge of analytical method transfers and analytical method validation/verification.

• Exceptional knowledge in laboratory equipment qualification principles.

• Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).

• Advanced knowledge and interpretation of cGMP, ISO, FDA, MHRA and Pharmacopeia requirements, and good documentation practices.

• Advanced knowledge of Data Integrity principles, familiar with audit trail review requirements.

• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook)

• Effective verbal communication skills, ability to interact with different levels of the organization and departments.

• Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports).

• Proven analytical, problem-solving, and continuous improvement skills.

• Proven time management skills and a strong attention to detail.

• Ability to work independently and compliantly.

• Physical ability to perform tasks that may require prolonged standing, sitting, and other activities necessary to perform job duties.

• Fluent in English or French and professional command of the second language (written and verbal).

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1580963

Updated: 2024-05-18 02:14:25.439 UTC

Location: Boudry-CHE

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.