Requirements: English
Company: TN Switzerland
Region: Boudry , Neuchtel
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Sr. Specialist Scientist QC Analytical Technical Support, Boudry
Client: Bristol Myers Squibb
Location: Boudry
Job Category: Customer Service
Job Reference:
09a6cfa0cd73
Job Views:
1
Posted:
15.04.2025
Expiry Date:
30.05.2025
Job Description:
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.
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:
- 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, participates in investigations and identifies measures to prevent similar accidents in the future.
- Demonstrates 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-