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Global Biologics Stability (GBS) manages the stability programs for Bristol
Myers-Squibb’s commercial biologic Drug Substances and Drug Products. The
global stability program supports all internal and external manufacturing
sites. The senior scientist reports to the Associate Director of GBS and is
responsible for stability product strategy and oversight of product stability
programs. Activities include those associated with product stability strategy,
stability program requirements, approval of stability protocols, and
preparation, review and approval of stability reports and regulatory filings.
Provide oversight and leadership to one or more commercial stability programs.
Sciences, and manufacturing sites to develop stability product
requirements for annual enrollments, process changes and investigations.
Determine the stability requirements for each commercial product based on
technical rationale and globally approved dossiers. Provide testing
projections to the QC laboratories.
are completed per site and brand timelines.
assessment in change controls. Review and endorse change controls as an
expanded reviewer. Initiate change controls related to stability
operations or product shelf life extension.
and approve study specific protocols or batch enrollment forms. As
needed, review and activate LIMS stability studies.
Perform stability impact assessments as required.
Authority submissions and responding to Health Authority Queries. Point
person for global rollout of observations that may affect stability
programs and develop strategies to close gaps/mitigation.
development of company-wide Stability directives.
impact lab capacity, product studies or regulatory commitments directly
and promptly to management
Ensure training requirements are met.
management of stability programs.
KNOWLEDGE AND SKILL
experience in biopharma at BMS or other company
(Q1A, Q5C) and associated policies, directives and guidance documents. A
thorough knowledge of cGMP regulations as referenced in The Code of
Federal Regulations (21CFR) and their specific application to stability
programs in a biologics manufacturing facility.
stability strategy to technical teams and in change control and
investigations management system. Ability to work collaboratively in a
team matrix environment is required.
using statistics and statistics software.
manufacturing processes, analytical and/ or Microbiology methods
problem solving and analytical thinking.
accomplishment in continuous improvement. Prior experience with
commercial stability trouble-shooting and demonstrated expertise in
Biologics or Protein Therapeutic molecule
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.- Knowledge of US/EU/ROW
Requirements, Corporate Directives and industry best practices; develops
strategies for solving complex problems/issues; recommending and driving
implementation of solutions. Use computer software/programs Microsoft Office
applications, SAP, LIMS, Trackwise, JMP, etc.
Sr Scientist works on problems of diverse scope in which analysis of situation
or data requires evaluation of identifiable factors.
selecting methods and techniques for obtaining solutions.
costs and personnel, and serious delays in overall schedules.
establishes goals to meet objectives.
Provides guidance to subordinates to achieve goals in accordance with
Work is reviewed and measured based on meeting established objectives and
Identifies and reports any discrepancies from normal practices or procedures to
senior management, recommending and implementing corrective actions.
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 the resources to pursue their goals,
both at work and in their personal lives.