Bristol Myers Squibb
BioPharma/Pharmaceutical
AnalyticalTrendingScientist
Neural analysis suggests this role is
optimal for Mid candidates.
“Analytical Trending Scientist at Bristol Myers Squibb. Skills: Stability data analysis, Stability data reporting, Stability data trending, Statistical software. Facilitate initiation of commercial stability studies. Track enrollment of stability batches”
Industry & Context.
Ability to identify, manage, and/or escalate issues and risks; Demonstrated ability to recognize anomalous trends or results; Exercise sound judgment, using a risk-based approach
What They're Looking For.
Must Have
Bachelor's degree, 5+ years experience in BioPharma/Pharmaceutical industry, working knowledge of stability ICH Guidelines (Q1A, Q5C), knowledge of cGMP regulations (21CFR), Excellent written and verbal communication skills, Ability to work collaboratively in a team matrix environment, Ability to identify, manage, and/or escalate issues and risks, Significant experience evaluating and interpreting stability data, Very good understanding of pharmaceutical regulatory requirements, Very good understanding of regulatory and stability guidelines, Very good understanding of storage requirements and cGMP, Working knowledge of LIMS software, Working knowledge of trending / statistical software, Working knowledge of drug substance and drug product manufacturing, Good understanding of analytical and microbiological methods, Demonstrated ability to recognize anomalous trends or results, Able to prioritize objectives, Fluent in English
Nice to Have
Cross-functional experience in research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT
What You'll Do.
Facilitate initiation of commercial stability studies
Track enrollment of stability batches
and report stability data
Author stability initiation documents
Create and track stability annual requirements
Perform batch identification
Perform LIMS study creation
Perform stability data entry
Develop expertise on product stability performance
Author stability sections of CTD dossiers
Support Change Controls and CAPA’s
Follow department stability procedures
Ensure consistency with procedures
Support health-authority inspections
Own departmental deviations
Ensure training requirements are met
Identify/meet key milestones
Exercise sound judgment
How You'll Work.
Team & Collaboration
Ability to work collaboratively in a team matrix environment; Contribute to meeting team goals; Resolve complex issues
Communication Scope
Excellent written and verbal communication skills; Communicating stability strategy to technical teams; Change control management; Investigations management
Process & Methodology
Effectively manage projects, Identify/meet key milestones
Full Job Description
**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](https://careers.bms.com/working-with-us). Job Description **Key Responsibilities** * This position is responsible for facilitating the initiation of commercial stability studies, tracking the enrollment of stability batches, assembling, analyzing and reporting of stability data. * The responsibilities include authoring stability initiation documents and other related documents including the Master Stability Protocols, Study Specific Protocols, CMO Stability protocols and Batch enrollment forms. * Responsible for creation and tracking of the stability annual requirements, and year end requirement check * Responsible for batch identification as per annual program * Responsible for LIMS study creation and data management. * Responsible for stability data entry, reporting and trending into reports (e.g. Annual Product Quality Reports, Annual Reports, Annual Product Stability Reviews, and other reports). * Assembles, reviews and trends stability data from either internal or external sources using statistical packages (e.g. JMP). * Develops and maintains expertise on the
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