Bristol Myers Squibb Company

Laboratory Instrumentation Program Lead

Location
New Brunswick, NJ, United States
Posted
Sep 12, 2020
Ref
R1528375
Required Education
Bachelors Degree
Position Type
Full time
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 successful candidate will be responsible for leading program and best practices for the lifecycle management of analytical instruments and equipment. Point of support for scientists for the instruments and equipment management to insure compliance with validation, qualification and data integrity requirements.

They will also integrate regulatory and quality guidance and portfolio priorities to enable GMP laboratories to generate accurate, reliable, timely and secure data in support of filings and operations.

Responsibilities:
  • Write installation/operation/performance qualifications protocols
  • Prepare validation plans and summaries
  • Maintain calibration and requalification schedules and monitor adherence
  • Prepare of data integrity risk assessments
  • Conduct benchtop computer and instrument periodic reviews
  • Guide laboratory personnel in preparation of plans, protocols, assessments, reports and change controls
  • Oversee service engineer's work on instrument maintenance and qualification
  • Point of contact with the laboratory Asset Management Team
  • Insure qualification program and documentation is compliant with procedures
  • Guide on change control and decommissioning planning, impact evaluation and documentation activities
  • Ensure and guide on proper practices of instrument management software
  • Provide training on instrument lifecycle management to scientists
  • Prepare and update standard operating procedures
  • Identify, report and document deviations to standard operating procedures and data management
  • Innovate to impact the continues improvement of instrument and equipment qualification and data integrity
  • Lead teams on initiatives with membership form the operations, laboratories, quality assurance and IT


Requirements:
  • Bachelors or Master's Degree, preferably in the biological or chemical sciences, with 10 or more years of relevant experience in biologics development/pharmaceutical industry or equivalent, in a GMP environment.
  • At least 3 years' experience in qualification of analytical instruments
  • Experience as subject matter experts during audits
  • Knowledge of GMP and good documentation practices
  • Experience in preparation of instrument and equipment qualifications
  • Exposure to computer system validation
  • Experience in application of GAMP and ISO 17025 to instruments and equipment lifecycle.
  • Experience with inventory equipment management software
  • Strong problem solving skills, verbal and written communications skills
  • Demonstrated ability to work independently, collaborate effectively in matrix environment and drive deliverables
  • Experience in project management is a plus
  • Ability to coordinate/execute multiple schedules and qualification packages
  • Proficient with Microsoft Office Suite


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.