Bristol Myers Squibb
Biopharm/Pharmaceutical
AnalyticalTrendingScientist
Neural analysis suggests this role is
optimal for Mid candidates.
“Analytical Trending Scientist at Bristol Myers Squibb. Skills: analytical verification programme (CAV), method performance monitoring, QC trending, cGMP regulations, data analysis. Engage with internal QC laboratories in the BMS network to ensure data is collated as required to support needs of the continuous analytical verification programme (CAV). Engage with external QC laboratories to gather data in approved formats (where agreed)”
Industry & Context.
demonstrated ability to recognize anomalous trends or results
What They're Looking For.
Must Have
Bachelor’s degree in a life science field, 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 analytical testing methods and pharmaceutical manufacturing, knowledge of QC trending guidelines, directives and associated policies, 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, 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.
Engage with internal QC laboratories in the BMS network to ensure data is collated as required to support needs of the continuous analytical verification programme (CAV), Engage with external QC laboratories to gather data in approved formats (where agreed), Support the review of method performance monitoring data to an agreed frequency, including control charting, assessment and follow up activities with SME, Review and perform assessment of cross site invalid rates and method performance monitoring for internal and external QC laboratories, Support new or updates to CAV documentation e.
g SOP’s, method performance monitoring reports, master plans, dashboards, Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.
TrackWise or Veeva), JMP, data management software (e.
Power BI), visualization software for trending etc., Support generation of new or revised control limits to support the method performance monitoring programme, Collate data to support the End-to-End business review process, Support other ad hoc requests for data, Support communication of risks at Tier 1 meetings, Support process improvement initiatives within the CAV programme, Support automation activities identified to be appropriate for the CAV programme.
How You'll Work.
Team & Collaboration
Engage with internal QC laboratories in the BMS network; Engage with external QC laboratories; follow up activities with SME; Ability to work collaboratively in a team matrix environment; Support communication of risks at Tier 1 meetings
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
Ability to identify, manage, and/or escalate issues and risks to timelines, Able to prioritize objectives from multiple projects, and deliver according to overall strategy
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). **Key Responsibilities** * Engage with internal QC laboratories in the BMS network to ensure data is collated as required to support needs of the continuous analytical verification programme (CAV). * Engage with external QC laboratories to gather data in approved formats (where agreed). * Support the review of method performance monitoring data to an agreed frequency, including control charting, assessment and follow up activities with SME. * Review and perform assessment of cross site invalid rates and method performance monitoring for internal and external QC laboratories. * Support new or updates to CAV documentation e.g SOP’s, method performance monitoring reports, master plans, dashboards. * **Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, data management software (e.g. Power BI), visualization software for trending etc.** * Support generation of new or revised control limits to support the method performance monitoring programme. * Co
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