Senior Scientist, Method Execution & Instrument Integration

Posted:
11/25/2024, 11:22:36 AM

Location(s):
Leinster, Ireland

Experience Level(s):
Senior

Field(s):
Data & Analytics

Workplace Type:
Hybrid

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: careers.bms.com/working-with-us.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility.  This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.  

Position Summary
As a Senior Scientist in the Lab Digital Sciences organization, you will play a pivotal role in advancing digital capabilities for our QC labs now and into the future to help accelerate the delivery of more medicines to patients faster.  As a technical leader within the QC Digital System Business Technical Support pillar, you will be at the forefront of developing and maintaining the critical master data and analytical workflows that are foundational to enabling paperless labs and evolving as technology advances. Your work will directly impact site manufacturing, including New Product Introduction (NPI), product release decisions and data analytics monitoring stability, product, and method performance, accelerating the delivery of quality medicines to patients.  

 

Technical leadership responsibilities include ensuring compliance with procedures, methods, specifications, sampling plans, and data reporting requirements including, but not limited to, raw material, consumable, water, microbial, biologics drug substance and/or drug product testing.  This role 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 digital systems to meet business and agency requirements with operational efficiency in mind

Key Duties and Responsibilities:

Method Execution 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 within the lab system. 
  • Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up.
  • Contribute to identifying opportunities and executing actions to standardize and simply operations.
  • Test changes/enhancements through dry runs and receive feedback from lab users. 
  • Setup verification testing as appropriate for the lab system.   
  • 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 and developing actions to address challenges/opportunities to improve. 
  • Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content. 
  • Assist with recruitment, integration, and training of less experienced Superusers on use of lab systems. Train users on overview of system.
  • Provide ad hoc support to users for issues/questions on the lab system. 
  • Act as team representative in regulatory inspections and internal audits.
  • 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.   
  • Lead/participate on teams in support of digital transformation, business process improvements/operational excellence. 
  • Lead/Participate on small / medium project teams, execution & visibility to status 

QC Digital Transformation:

  • Support execution of digital science project deliverables across multiple functional areas/project teams to ensure successful delivery of future ready lab digital systems. 
  • Aid in change management efforts to facilitate the adoption of lab digital system changes, ensuring user acceptance and compliance.
  • Contribute to development and implementation of training programs to ensure effective user adoption of lab digital systems. 
  • Lead/contribute to change activities to support development and implementation of new global procedural documents and training programs for lab digital systems. 
  • Support workshops with end-users and superusers to ensure effective change management. 

Qualifications & Experience

  • Minimum B.S. degree in a scientific area with 6 to 8 years’ experience minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years’ experience.   
  • 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 lab digital system master data configuration, preferably with experience in QC analytical techniques/operations.
  • Deep functional area understanding and high level of proficiency in the technical aspects of one or more system capabilities (Environmental Monitoring, Sample & Inventory Management, Release, In-Process, Stability, 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, proficiently 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.
  • Strong organization and time management is essential.  Ability to manage & execute multiple objectives/projects and prioritize as needed.
  • Ability to take initiative; 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.

Why you should apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Hybrid

If you come across a role that intrigues you but doesn’t 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, Life-changing 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 an inclusive culture, promoting diversity 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.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design 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 field-based and remote-by-design 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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 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: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb

Website: https://bms.com/

Headquarter Location: New York, New York, United States

Employee Count: 10001+

Year Founded: 1887

IPO Status: Public

Last Funding Type: Post-IPO Debt

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine