Senior Process Engineer

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.

Bristol-Myers Squibb R&D External Manufacturing (RDXM) ensures that clinical Drug Substance and Drug Product are delivered on time and in high quality from our external and internal manufacturing network. As a Senior Process Engineer, you will provide technical subject matter expertise to ensure the successful manufacture of small molecule API and chemical intermediates, biologic Drug Substance, and other specialty materials to support development of R&D pipeline products. In addition, the Senior Process Engineer is expected to provide guidance to junior staff, improve workflows and practices, and contribute strategically to the Process Engineering group.

This role requires that ability to work with BMS functions and Contract Manufacturing Organizations, with a focus on understanding the risk to quality, yield, and timelines from the technical implementation of BMS processes at remote CMO sites. A successful candidate must be able to learn, adapt quickly to a change, and demonstrate flexibility when new challenges are presented. Although most of the manufacturing will be at external partners, candidates must have experience working in a pharmaceutical plant environment and a deep understanding of procedures and equipment necessary for pharmaceutical manufacturing.

Key responsibilities include:

• Providing engineering expertise for technology transfer to internal and external manufacturing sites, from pre-clinical development through process Validation
• Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies
• Partner with internal and external groups to ensure technical success of technology transfer and manufacturing
• Provide on-site support for CMO's as-needed for successful process implementation
• Mentoring/training junior personnel
• Contributing to Process Engineering and RDXM business teams through innovation, strategic input, and industry knowledge
• With scientific teams, guide R&D plans to inform process transfer, development, and scale up
• Review and/or author technical documentation to ensure high technology transfer fidelity and minimize errors in manufacturing execution
• Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents
• Provide process engineering expertise to the Hazard Evaluation Lab and the Process Hazard Analysis team
• Provide process expertise in post-batch record review and analysis
• Act as a quality events investigator for assigned projects.

Qualifications

• Must have a minimum of 2 years' experience in commercialor pilot manufacturing of Drug Substance, chemical intermediate, and/or specialty material
• Must havea B.S. or advanced degree in Chemical Engineering or a related discipline with a minimum of 6-8 years relevant industrial experience in process scale-up or process development
• Strong technicalskills (process development, chemistry, chemical processing equipment), with a proficient understanding of GMP and safety regulations is required.
• Strong knowledgeofplant scaleunit operations,scale-up, process fit, equipment capabilities, and process implementation
• Excellent problem solving skills and abilityto workeffectively with multiple assignments
• Demonstratedabilityto work independently or as part of multidisciplinary project team.
• Essentialto success is the ability to build strong working relationships with internal and external partners, to apply cooperation principles, and perform strongly in a matrix environment.
• Demonstrated strength in allmodes ofcommunication with internal and external partners.
• Up to 10-25%percent domestic and/or international travel annually.

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.