Bristol Myers Squibb
Biopharm/Pharmaceutical
AnalyticalInstrumentLifecycleScientist
“Analytical Instrument Lifecycle Scientist at Bristol Myers Squibb. Skills: Analytical Instrument Lifecycle Management, cGMP Regulations, Project Management, Stakeholder Management, Risk Management. Define the analytical instrument standard for each test method and product within global QC labs. Actively manage the instrument obsolescence 5-year plan”
What You'll Achieve.
ensure replacement projects are initiated and completed on time to avoid impact to QC testing; maintain visibility globally of our instrument inventory across QC sites; meet key milestones
Industry & Context.
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies; demonstrated ability to recognize anomalous trends or results
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 (for field-based and remote-by-design roles)
What They're Looking For.
Must Have
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), 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, 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, Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
What You'll Do.
Define the analytical instrument standard for each test method and product within global QC labs
Actively manage the instrument obsolescence 5-year plan
Define the annual instrument and software obsolescence book of work and project management of associated activities
Compile the analytical instrument forecast for new product introductions or transfers to QC laboratories
Update and maintain the QC laboratories analytical instrument register and documentation database
Provide visibility to stakeholders on the status of instrument qualifications and instrument replacement projects
Lead monthly project tracking meetings with stakeholders
Assist in compiling the annual instrumentation budget recommendations
Convene recurring meetings with stakeholders to manage the book of work
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
How You'll Work.
Team & Collaboration
Ability to work collaboratively in a team matrix environment; Lead monthly project tracking meetings with stakeholders across the network; Convene recurring meetings with stakeholders to manage the book of work; Support cross-site collaboration to enable leveraging of instrument related documentation
Communication Scope
Excellent written and verbal communication skills in communicating to technical teams and in change control and investigations management system; Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
Process & Methodology
Project management of associated activities, Effectively manage projects, Ability to identify, manage, and/or escalate issues and risks to timelines
Applying for this Analytical Instrument Lifecycle Scientist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Bristol Myers Squibb?
Real rants from real employees. Read before you apply.