Bristol-Myers Squibb Company

LIMS Data Analyst

Location
Hopewell, NJ, US
Posted
May 12, 2018
Ref
R1502380
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The Hopewell Sample and Data Management group, within the Analytical & Bioanalytical Operations organization, is the central group for managing samples and data related to testing of new biologics drugs for clinical trials.

This position will primarily focus on the roll-out, implementation, and maintenance of Sample Manager (SM) LIMS at the Hopewell site that supports testing throughout the biologics network.This position will be responsible for interfacing with stakeholders across the organization (e.g., other site SMLIMS teams, Clinical Stability, Global SMLIMS team, Hopewell IT, Hopewell scientists, and external partners) to implement the static data builds for stability studies, methods and analyses, and configuring the appropriate study plans, templates, product specifications, reports, and graphs within LIMS.

Main Responsibilities:
  • Review in-process, release, and stability testing plans for SMLIMS configuration, collaborate with appropriate scientists and other laboratory personnel to create and maintain static data (templates and analyses) within Sample Manager LIMS to support laboratory activities
  • Collaborate with Biologics Development IT department to ensure that templates and analyses are configured in a re-usable and standardized manner, and enables data mining and trending
  • Test new functionality, support scientists as the scientists test new templates, and make necessary changes, in an iterative manner
  • Collaborate with partners to identify user requirements and write and execute User Acceptance Testing for LIMS application upgrades
  • Understand requirements for ad hoc reports, and configure as needed
  • Understand how workflows, and user needs can be optimized, and collaborate with the laboratories and IT to implement those changes
  • Develop and sustain procedures/work instructions for use of the SMLIMS system
  • Train users and less experienced staff on use of SMLIMS
  • Provide ad/hoc support for users with issues/questions on use of the LIMS
  • Participate in teams in support of business process improvements/operational excellence in support of testing and data management leading to use of SMLIMS to trend method and reference standard performance
  • Collaborate with IT to ensure that the connection between Velquest Smartlab Lab Execution Method (electronic laboratory notebooks) and Sample Manager LIMS is functioning and optimal
  • Collaborate with other Biologics Development clinical and commercial sites to align processes
  • Run reports and queries to support business needs
  • Integrate sample chain of custody functionality throughout the business process


Minimum Qualifications
  • Bachelors or Master's Degree, preferably in the biological or chemical sciences, with at 4-6 years of relevant experience in biologics development/pharmaceutical industry or equivalent, in a GMP environment.
  • Additionally, 2-5 years of demonstrated experience with a LIMS system in an administrator or business analyst role (Sample Manager LIMS preferred)
  • Experience running biological or chemical assays (e.g. HPLC/UPLC, ELISA, environmental monitoring, raw material, or compendial test methodologies) is a plus.
  • Demonstrated ability to elicit, interpret, and document business and functional requirements into software functionality
  • Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
  • Skill in communicating/escalating critical issues to appropriate management is necessary.
  • Strong written and oral communication skills with the ability to train others is essential and a background in project management skills is a plus.
  • Experience with Process improvement methodologies (Six Sigma, Lean Sigma) is a plus.