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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Manager Technical Lead

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeDublin, Ireland

About the Job

Requirements

  • At least 5 years of experience in a GMP environment, including at least 2 years of Sterile Drug Product manufacturing.
  • A strong understanding of Sterile Drug Product manufacturing operations, including formulation, filling, capping, lyophilization, visual inspection, and equipment preparation, is highly desirable.
  • Experience working in a sterile manufacturing facility and demonstrated technical troubleshooting and problem-solving capabilities are preferred.
  • Ability to adapt flexibly to changing business needs in a start-up environment.

Responsibilities

  • Provide on-the-floor technical leadership to manufacturing teams within the new Sterile Drug Product facility.
  • Serve as a manufacturing subject-matter expert in one or more processes, including formulation, filling (vial and syringe), lyophilization, capping, visual inspection, and primary packaging.
  • Lead technical issue troubleshooting and resolution during and after facility start-up.
  • Work with cross-functional departments to facilitate implementation of the project design and validation of the Sterile Drug Product manufacturing facility.
  • Support all phases of commissioning, qualification, and validation during the start-up phase of the facility.
  • Support capital, technical transfer, and operational readiness activities, including vendor site Factory Acceptance Tests, Manufacturing Execution System and Master Batch Record design, standard operating procedure development and implementation, training material development, room layouts, and ways of working.
  • Support delivery of training to the Sterile Drug Product team on day-to-day operations within the area of responsibility.
  • Work with the Shift Lead and Technical Lead to build the Sterile Drug Product manufacturing teams’ technical competencies within a given area.
  • Lead right-first-time execution of commercial manufacturing processes within areas of responsibility.
  • Support key meetings on behalf of Manufacturing.
  • Support and lead operational excellence initiatives, including 5S, Standard Work, Leader Standard Work, Kaizen, and problem-solving activities.
  • Support operational investigations and serve as the key point of contact for investigations led by other functions.
  • Serve as a subject-matter expert in process automation systems, including DeltaV, Syncade interactions, and OSI/Pi Historian, and supporting business systems, including SAP, TrackWise, and Maximo.
  • Coordinate batch and exception report delivery review for manufacturing lots with the Quality Assurance representative for the area of responsibility.
  • Drive and support continuous improvement initiatives and safe working practices.
  • Act as designee for the Technical Lead when required.
  • Support other business deliverables as needed.

Desired Qualifications

  • A Bachelor's degree in Science, Engineering, or a related discipline.
  • Experience with lean manufacturing techniques and tools.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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