QC Scientist - Instrumentation

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.

The Scientist will join the Technical Support team of the Quality Control (QC) department of Celgene, Switzerland. The QC department is responsible for testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms manufactured at the site. The Scientist will provide technical and scientific expertise to support acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories. Additional duties will include performing superuser activities for the laboratory computerized systems, representing QC in cross-functional projects (e.g. for new product implementation) and participating in internal and external audits as Subject Matter Expert (SME).

Duties and Responsibilities

• Is responsible for acquisition and qualification of new analytical equipment:
  • Works cross-functionally with Analytical Science & Technology, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories.
  • Owns the change control, leads or supports risk assessments,
  • Performs feasibility experimental work as needed
  • Configures user profiles and methods on the instrument.
  • Collaborates with Validation and Sourcing 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.
  • Provides guidance for confirmatory testing.
  • Writes or reviews investigative testing plans to identify laboratory root cause.
  • Writes or reviews retest plans prior to execution.
  • Defines corrective and preventive actions (CAPA).
• Represents QC in project teams (e.g. for new product introductions to the site)
  • Represents QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology.
  • Supports QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning.
  • Leads or supports risk assessments, owns change controls.
• Superuser 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, trains QC analysts on use of the system.
  • Performs master data management activities in computerized systems (LIMS, Oracle, Empower).

Required Competencies: Knowledge, Skills, and Abilities

• BS degree in Life Sciences, Chemistry, or equivalent;
• 5 years of work experience in a GMP environment (pharmaceutical industry)
• Advanced knowledge and interpretation of cGMP and ALCOA+ principles
• Good scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS and IR techniques.
• Experience in qualification of laboratory equipment and computerized systems.
• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
• Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).
• Good knowledge of Data Integrity principles, familiar with data flow maps and audit trail review requirements.
• Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments
• Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
• Takes a structured and analytical approach to problem-solving. Is familiar with problem-solving and investigation tools and methodologies.
• Ability to work collaboratively and cross-functionally in project teams.
• Fluent in English or French and professional command of the second language (written and verbal)

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.