LIMS Manager

Location
Celgene, NJ, United States
Posted
Sep 17, 2020
Ref
R1529721
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.

Competences

In this position, the LIMS Manager is responsible for oversight of daily activities pertaining to the LIMS system to ensure that laboratory activities recorded in the system can be completed and documented in an accurate, consistent and compliant manner.

The position is responsible for developing, managing, coordinating people and processes around LIMS master data, user management, and super user duties. The role will also be involved/and or lead future improvements and deployments of the system

This position will interact with Global and local IT groups, LIMS System Admins, QC Management, LIMS End-Users in QC and Manufacturing, Quality Assurance and other internal and global stakeholders.

The LIMS Manager may also act as a backup for responsibilities for the Associate Director, Labware. Extended hours and on-call support may be required.

Skills/Knowledge Required
  • BS degree in Science, Computer Science or a related field.
  • A minimum of 8 years of relevant work experience in a GMP regulated environment (or equivalent)
  • Previous experience in a GMP QC role.
  • Advanced knowledge of LIMS applications and procedures (Labware a strong plus)
  • Knowledge of cGMP Regulations and how they apply to QC laboratories
  • Solid understanding of end-to-end QC processes, laboratory data and instrumentation.
  • Advanced knowledge of validation and/or maintenance of laboratory information systems
  • Advanced understanding of laboratory electronic system design and use.
  • Intermediate knowledge of data integrity principles and data governance strategies.
  • Intermediate presentation, management and organizational skills.
  • Intermediate project management skills.
  • Ability to work independently for extended periods of time.
  • Ability to effectively collaborate cross-functionally to drive effective communication
  • Excellent English verbal and written communication skills
  • Customer focused and results driven
  • Proven time management skills and a strong attention to detail
  • Proven analytical and problem-solving skills
  • Ability to work independently and compliantly.
  • Ability to work and manage remote teams.
  • Proficient in using various types of computer software (Word, Excel, PowerPoint, Outlook, Visio)


Duties and Responsibilities

BMS has embarked on a global roll-out of LabWare LIMS (CELabs) with plans to roll-out to multiple facilities/sites

CELabs Program project phase: MDM build and Site Deployment

During the Site deployment phase of CELabs LIMS releases, the LIMS Manager will coordinate on:
  • Understanding the release scope.
  • Supporting the gathering of documentation for the collection of Master Data using the LIST Template(s).
  • Standardizes and harmonizes master data per standards documented in the MD SOPs/WPs.
  • Suggests known opportunities for harmonization.
  • Consults and/or manages LIMS Specialists and Site SMEs to provide data and answers to questions.
  • Coordinate on the reviews of the master data prior to build and on the verification and User Acceptance Testing of completed master data as needed.

In addition, support the Site Deployment teams with the following duties:
  • Demos and testing of functionalities and workflows.
  • Design, review and/or execution of user acceptance testing (UAT) protocols.
  • Development and delivery of training material.
  • Creation and/or update of local GMP procedures.
  • Change Management.
  • Hypercare activities.

Following Site deployment and for sites under responsibility, the LIMS Manager will be responsible for the Business-as-Usual (BAU) Support.

System Management:
  • Execute, create or revise validation documents (i.e. UAT, URS, OQ, PQ, etc.) as applicable.
  • Support Business buildouts and LIMS changes
  • Support IT in the Administration of the LIMS System.

System Support
  • Ensure first-line operations support to end users
  • Ensure first line coordination with Local IT/Tech support and system admins
  • Assist with errors and solve problems with minimum guidance; perform simple data fixes.
  • Provide expertise in the execution of business processes using LIMS.
  • Provide expertise in the development of system enhancements with user requirements and business drivers.
  • Ensure the support for site projects and goals where applicable to streamline testing.


Master Data Management:

  • Ensure the update of master data objects
  • Triage, assess, align and execute non-configuration related build.

People Management:
  • Coach and develop direct reporting LIMS Specialists to ensure they have the skills and abilities to perform the duties assigned to them.
  • Participate in hiring processes internal and external to the group.
  • Determine group training curricula and oversee development of training content.
  • Provide feedback to direct reports through regular coaching sessions.
  • Utilize company-guided performance management tools and processes.
  • Drive sense of team responsibility for group's success.


CELabs User Council:
  • Be an actor on the CELabs User council.
  • Work cross-functionally to share best practices and determine solutions that benefit all sites using CELabs.
  • Participate in enhancement planning to comprehensively ensure requisite resources and technology are included.
  • Ensure appropriate and effective level of understanding of site needs to appropriately schedule and complete activities as committed.


  • Performs all activities in compliance to cGMP requirements and applicable standards and procedures.
  • Comply to EHS rules and safe work practices per applicable procedures.
  • Own or support change controls for LIMS changes
  • Lead or support investigations in case of LIMS-related deviations and own any CAPA follow ups.
  • Participate as required in inspections by health authorities and in corresponding preparation as LIMS SME.

Performs other tasks as assigned.

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.