Analytical Subject Matter Expert Quality Operations
Bristol-Myers Squibb
vor 2 Tg.

Bristol-Myers Squibb is a global

Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

In this position you will be responsible to represent GCH in relevant Global Manufacturing and Supply (GPS) projects as a subject matter expert in all aspects related to analytics / test methods / laboratory and is link to product stability teams.

Work in close cooperation with other Biologics Analytical SME plus the wider commercial analytical communities, e.g. Analytical Science and Technology (AST), to transfer to and maintain methods at testing laboratories, whether dedicated contract testing laboratories (CTL) or embedded at the Contract Manufacturing Organization (CMO).

This position requires working in a matrix with several local and global functions (e.g. Supplier Relation Manager (SRM), Project Manger (PM), Supply Chain (SC), Quality Operations (QO), Product Quality Lead (PQL)) internal and external to BMS across multiple countries and time zones to fully support technical transfers and commercial production.

This position will oversee method robustness including level one troubleshooting.

Key responsibilities :

  • First line point of contact and day-to-day management of relationship between CMO / CTL and BMS within Quality Controll (QC) functions.
  • Develop working relationships with CMO / CTL laboratory management to facilitate successful collaboration as well as issue resolution.
  • Lead troubleshooting of methods and resolve analytical issues at CMO / CTLs.
  • Point of contact with Analytical Science and Technology (AS&T) to obtain Subject Matter Expert (SME) input for more complex analytical issues.
  • Review and approve QC labs investigations as technical SME to ensure thorough root cause analysis and effective CAPA.
  • Review and approve method validation / qualification documentation as technical SME for work performed at a CMO / CTL.
  • Order critical reagents according to CMO request and ensure timely shipment
  • Maintain consistency of client methods / specifications at CMO / CTLs with primary BMS source documents
  • Partner with AS&T to ensure robust transfer of methods (release and in-process) and timely completetion into CMO / CTLs.
  • Perform method robustness monitoring for each CMO / CTL on a routine basis escalating any potential trends. Partner with AST to maintain commercial methods throughout the product lifecycle
  • Support Health Authority Inspections, assist with inspection preparation at CMOs / CTLs.
  • Originate / review change controls records and manage the change implementation at CMO / CTLs.
  • Align and maintain collaborative partnership with internal BMS functions such as AS&T, Manufacturing Science and technology (MS&T) and Biologics External Manufacturing.
  • Establish and maintain close collaboration with Supplier Relations Managers (SRM) and Supply Chain for accurate sample forecasting.
  • Provide sample management and testing strategies during product transfer projects and product life cycle.
  • Identify and align in collaboration with BMS Global Stability Center (GSL) the annual market life stabilities and qualification stabilities.
  • Required Competencies :

  • Strong strategic and analytical thinking, problem solving and rapid decision making skills.
  • Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment.
  • Strong ability in negotiating and influencing without line authority in complex, high impact situations.
  • Demonstrated ability in technical writing, computer knowledge and communication skills.
  • Strong presentation and communication skills both, oral and written.
  • Required Qualification(s) and Desired Experience :

  • Ph. D. in biochemistry, chemistry, biochemical engineering, or a related discipline with 5-10 years of related experience.
  • MS degree with 10-15 years experience will also be considered

  • Extensive knowledge of biochemical, cell-based and chemical analytical methods, method development and validation.
  • Experience in pharmaceutical biologics manufacturing of commercial and clinical drug substance and drug product and / or in quality control is highly desirable.
  • Knowledge about biological product stability studies is desirable.
  • Ability to summarize and discuss complex data sets and topics in various settings; demonstrate analytical and strategic thinking.
  • Work in a multi-disciplinary team, partner with the product development team while providing strong leadership to drive decisions and knowledge of the IPC data in drug manufacturing.
  • Experience in working in an international environment with matrix organization.
  • Demonstrated expertise in performing investigations applying thorough root cause analysis and in use of risk assessments.
  • Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP, GLP and regulatory requirements are met.
  • Sound knowledge of the requirements from international pharmacopoeias regarding analytical methods and lab environment.
  • Fluency in English.
  • BMS BioPharma Behaviors The qualified candidate demonstrates the characteristics of our BMS BioPharma Behaviors. For more details refer to InSite BMS Website / People and Performance / BMS BioPharma Behaviors.

    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.

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