Senior Technical Lead, Labware

Job content

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 Role

Bristol Myers Squibb is looking to recruit a permanent Senior Technical Lead, Labware.

Principle Objective of Position

This position is responsible for providing technical leadership and support in the development, implementation, and maintenance of static data/master data for QC lab system user workflows in support of site manufacturing, stability, method transfer and non-routine testing activities to ensure compliance with procedures, methods, specifications, sampling plans, and data reporting requirements for raw material, water, microbial, drug substance and/or drug product testing. This requires partnering with all levels of laboratory personnel, Information Technology, analytical support teams, and Quality Assurance to ensure processes are designed and maintained for lab systems to meet business and agency requirements with operational efficiency in mind.

Major Duties And Responsibilities

• Lead execution & contribute to development of lab system standardization plans. Enhance plans as business needs evolve. Lead alignment discussions to progress standardizations and escalate when required.
• Lead and drive the development and implementation of system enhancements to meet user requirements
• Develop/maintain processes/user workflows in lab systems to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
• Collaborate with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
• Develop and manage project plans and project schedules, lead execution and visibility of status and provide effective communications to customers and stakeholders. Assist with budget planning (resource requirements and other funding such as training, outside services, etc.)
• Lead new product implementation strategy for Lab Systems
• Assist with management of the day-to-day activities and prioritization of work and provide direction/support to team members.
• Contribute to the development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and developing/enhancing/tracking team metrics.
• Facilitate positive culture change with implementation of new processes.
• Provide leadership to peers through demonstration of a quality culture and scientific excellence.
• Attend Change Forums and serve as lab systems representative to coordinate Impact Assessment for all lab systems. Perform review of method/specification change controls, identify lab system impact, for area(s) of expertise and consolidate impact assessments for all lab systems to develop appropriate change actions required to support implementation of the change, including impact to interfacing systems. Collaborate with lab personnel, analytical support teams, and other relevant SMEs to assess impact to lab systems as needed.
• Execute and document lab system user workflow creations/revisions through the appropriate change control process and/or verify changes executed by a team member are accurate associated within the lab system.
• Test changes/enhancements through dry runs and test runs and receive feedback from lab users, when required.
• Setup verification testing as appropriate for the lab system.
• Design/Execute User Acceptance Testing for lab system application functionality changes.
• Review and Approve UAT Scripts and Coordinate UAT activities
• Communicate/coordinate system changes to integrated systems areas (i.e. trending system, MES, etc).
• Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory operations leveraging the lab systems.
• Author, revise, and/or review procedural documents, such as SOPs and WIs and associated training content.
• Develop and sustain training programs for use of lab systems, including user and data administrators.
• Train users and less experienced team members on use of lab systems ensuring cGMP procedures and associated training programs are in place to enable efficient / timely access to users.
• Provide ad hoc support to users for issues/questions on the lab system.
• Communicate technical issues and activity status updates to team members/direct supervisor and work with IT to resolve.
• Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.
• Lead/Participate on teams in support of business process improvements/operational excellence.
• Present information at group/department meetings.
• Provide support/direct interaction for internal compliance and regulatory agency inspections as SME in area(s) of expertise.
• Act as a primary delegate for System Business Owner.
• Escalate system issues to IT System Owner, BO & management as necessary
• Monitor & compile team metrics. Develop action plans to improve/enhance KPIs
  

Required Knowledge/Skills/Qualifications

Education

Minimum B.S. degree in a scientific area with 6 to 8 years’ experience

Experience/Knowledge

• Experience working within and/or supporting a cGMP laboratory is required.
• Demonstrated leadership ability within and across teams.
• Expert level applied knowledge and in depth understanding of analytical techniques preferred.
• Deep functional area understanding and high level of proficiency in the technical aspects of one or more systems, Empower, LES, LIMS, MODA, CIMS, etc. Advanced understanding of system interfaces and impact of changes to each other.
• Advanced knowledge with Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Word) and/or other relevant software programs
• Expert ability to execute changes in the lab system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.
• Demonstrated ability to work independently as well as lead a team to complete assignments within defined time constraints.
• Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.
• Ability to exercises judgment and makes sound decisions within broadly defined practices and policies to independently develop approach / solution. Apply appropriate notification to management as appropriate
• Demonstrated ability to effectively train and assist other less experienced individuals
  

Skills/Competencies

• Strong project management & execution skills, and is able to manage multiple projects and prioritize as needed.
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Self-directed with a high degree of professional integrity, very organized, and detail-oriented.
• Ability to build relationships cross functionally and influence internally/externally as appropriate
• Expert problem solving ability, attention to detail, and analytical/critical thinking skills.
• Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
• Minimal oversight is provided for this position. Incumbent works on assignments based on goals and objectives set annually and reviewed periodically with manager.
• This position may direct lower level employee work or act in place of a Team Leader.
• This position may require up to 20% travel.
  

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.