Bristol-Myers Squibb
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. 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.
Key Responsibilities
Define the analytical instrument standard (i.e. the default make, model, software version etc) for each test method and product within our global QC labs, in conjunction with the appropriate method subject matter experts. To include instruments required for pipeline products.
Actively manage the instrument obsolescence 5-year plan to ensure replacement projects are initiated and completed on time to avoid impact to QC testing.
Define the annual instrument and software obsolescence book of work and project management of the associated activities
Compile the analytical instrument forecast for new product introductions or transfers to the QC laboratories, and management of related actions.
Update and maintain the QC laboratories analytical instrument register and documentation database to maintain visibility globally of our instrument inventory across QC sites.
Provide visibility to stakeholders on the status of instrument qualifications in the QC laboratories and instrument replacement projects
Lead monthly project tracking meetings with stakeholders across the network and escalate any risks identified
Assist in compiling the annual instrumentation budget recommendations for internal QC laboratories
Convene recurring meetings with stakeholders to manage the book of work, collating agendas, meeting support materials, meeting minutes and action tracking.
Support the drafting, review and approval of governing procedures and associated training for analytical instrument lifecycle management.
Support cross-site collaboration to enable leveraging of instrument related documentation
Maintenance of the Analytical Instrument Lifecycle SharePoint site
Support the definition of a business case for continuous improvement initiatives
Supports activities involving Change Controls and CAPA’s
Supports health-authority inspection internal and external.
Ensures training requirements are met.
Effectively manage projects, escalate issues as necessary and identify/meet key milestones
Team leadership skills that contribute to meeting team goals and resolving complex issues
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
Qualifications & Experience
Education:
Minimum of a Bachelor’s degree
5+ years experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT)
Strong working knowledge and understanding of laboratory instruments qualification and lifecycle Regulatory Guidelines and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in key regulations such as The Code of Federal Regulations (21CFR), EMA Eudralex, USP and their specific application to stability programs in a pharmaceutical manufacturing facility
Excellent written and verbal communication skills in communicating to technical teams and in change control and investigations management system.
Ability to work collaboratively in a team matrix environment is required.
Ability to identify, manage, and/or escalate issues and risks to timelines.
Working knowledge of LIMS software, and trending / statistical software.
Working knowledge of drug substance and drug product manufacturing and good understanding of analytical and microbiological methods.
Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.
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 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.
On-site Protocol
BMS has an 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.
Supporting People with Disabilities
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1602023 : Analytical Instrument Lifecycle Scientist