At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Purpose and Scope of Position:
Reporting to the Technical Director of Data Science and Engineering within Global Manufacturing Science and Technology, this is a key role that will help define and contribute to an integrated strategy to drive process and product data acquisition and analysis capabilities across GMS&T and CTO. The scope will range across all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for vector and drug product processes (including clinical, but emphasis will be commercial).
This role will be responsible for developing technical standards and approaches to improve data analytics capabilities across the MS&T therapy processes, providing support for the continuous process verification (CPV) program and process/product knowledge development across products and sites. The role is expected to drive the availability of analysis-ready data for routine and ad-hoc monitoring and analyses. The role will also develop and refine standardized approaches to evaluating process capability, partitioning variation, and developing predictive models to explain and control process variation.
This role will interface with Biostatistics, Process Development, Site MSAT, Automation, IT, and other counterparts in the BMS Biologics and small molecule network to leverage expertise and knowledge across modalities. This role is expected to participate and network in external industry forums and conferences to influence and contribute to the evolution of advanced data acquisition and analysis practices to improve process and product knowledge. In addition to developing data strategies, standards, and tools, the candidate may lead small cross-functional teams to be deployed on a targeted basis to apply data analytics to technical investigations with the aim of identifying novel process and product insights/relationships and building capabilities.
Required Competencies (Knowledge, Skills, and Abilities):
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Effective technical and business influence capabilities in a matrix environment
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Excellent communication skills, both oral and written, including translation between process and data disciplines
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Ability to program in multiple languages (Python and R preferred)
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Software development experience utilizing multiple software development lifecycle approaches
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Experience with custom analytics development
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Sound background in statistics
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Strong technical coaching and mentoring skills
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Process and/or operational experience, including process, equipment, and system design
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Sound understanding of the global health authority expectations around process validation, including understanding and controlling variation
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Understanding of GMP concepts and quality systems, including data integrity
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Passion for excellence and curiosity for innovation
Required Education:
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Bachelor’s Degree in Computer Science, Chemical/Biochemical Engineering, or Life Sciences
Required Experience:
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With BS: Minimum 6 years of experience in industry, min 4 years of programming and modeling experience
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With MS: Minimum 4 years of experience in industry, min 4 years of programming and modeling experience
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With PhD: Minimum 2 years of experience in industry, min 4 years of programming and modeling experience
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Preference will be given to candidates with Cell Therapy experience, but not a requirement
Duties and Responsibilities:
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Define and implement an integrated strategy to drive process and product data acquisition and analysis capabilities across GMS&T and CTDO.
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Define technical standards that govern acquisition and analysis of process and product-related data for monitoring and analysis purposes
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Drive availability of analysis-ready data for routine and ad-hoc monitoring and analysis
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Develop standardized approaches and partner with stakeholder functions to evaluate process capability and partition variation between process, measurement, and materials
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Partner with stakeholder functions to develop models and insights, identifying variation reduction opportunities for high-value use cases
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Coach more junior engineers to build data engineering/ data science capability across GMS&T and CTDO using a coaching and ‘learn by doing’ model focused on high value use cases.
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Partner with stakeholder functions to ensure data availability is built into system designs with monitoring and analysis capabilities as a core requirement. Contribute to sanctioned projects as appropriate
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Travel as necessary, up to 15%
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Benchmark with Industry, identify and adopt best practices
Working Conditions:
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The position will work in an office environment and will need to write complex documents and final reports using a computer.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.