Senior Specialist Lab Systems
Senior Specialist Lab Systems
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1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams. Take your career farther than you thought possible.
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. Read more: Summary
This position is responsible for providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing stability method transfer and nonroutine testing activities to ensure compliance with procedures methods specifications sampling plans and data reporting requirements for raw material water microbial biologics drug substance and/or biologics 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.
Key Responsibilities:
Method and Instrument Integration:
Create maintain and review master data/static data in current/future lab systems by executing the appropriate change management process to ensure accuracy of the configured analytical workflow to support laboratory testing activities and to ensure business project and/or investigation/CAPA timelines are met.
Support review of change controls associated with lab systems identify system impact and develop appropriate change actions required to support implementation of the change including impact to interfacing systems.
Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system.
Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up
Execute standardization plan and contribute to identifying opportunities to standardize
Test changes/enhancements through dry runs and receive feedback from lab users when required.
Setup verification testing as appropriate for the lab system.
Execute User Acceptance Testing for system functionality changes.
Communicate impact of lab system changes to integrated systems areas (i.e. trending system MES etc..
Collaborate/liase with appropriate laboratory manufacturing analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
Evaluate recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e. visibility to testing queues testing metrics monitoring etc) to support product release new products and key performance indicators/lean lab metrics.
Contribute to the development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and tracking team metrics.
Assist with compiling/tracking team metrics.
Author revise and/or review procedural documents such as SOPs and WIs and contribute to the development of associated training content.
Communicate technical issues and activity status updates to team members/direct management.
Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.
Participate on/Lead teams in support of business process improvements/operational excellence.
Lead/Participate on small / medium project teams.
Lead/Drive & visibility to status
Present information at group/department meetings.
Qualifications & Experience
Minimum B.S. degree in a relevant scientific computer or engineering program area with at least 2 to 4 years experience.
Advanced knowledge and in depth understanding of analytical techniques preferred.
Proficient knowledge of a lab system such as Empower LES LIMS MODA CIMS etc. understanding of system interfaces and impact of changes to each other.
Proficient knowledge and understanding of Microsoft Office Applications (Access Excel Project PowerPoint SharePoint Teams Word) and/or other relevant software programs.
Demonstrated ability to work independently to complete assignments within defined time constraints.
Ability to execute changes in the lab system independently proactively identify problems troubleshoot issues and develop potential solutions.
Respond to system issues and troubleshoot to identify cause.
Ability to interpret and apply cGMPs regulatory requirements and industry best practices.
Ability to exercise judgment and makes sound decisions within generally defined practices and policies to independently develop approach/solution. Consult with technical if needed.
Demonstrated ability to effectively train and assist other less experienced individuals.
Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility independently or as part of a team. Selfdirected with a high degree of professional integrity very organized and detailoriented.
Demonstrated problem solving ability attention to detail and analytical thinking skills.
Strong interpersonal oral and written communication skills are essential. 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.
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work Lifechanging Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Senior IC
Employment Type
Full-Time
