Bristol-Myers Squibb is offering #job opportunity for a Process Analytics Engineer in Massachusetts,

Job Description

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.

Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.

The Engineer in the Process Modeling and Analysis(PMA) group within Manufacturing Sciences & Technology will be responsible for product robustness for the commercial biologics portfolio manufactured in Devens, MA and third party manufacturing sites. This position reports to the Associate Director of Process Modeling and Analysis.

The PMA team, located in Syracuse, NY and Devens, MA, is responsible for leading and reporting product robustness for biologics drug substance and drug product manufacturing. The group also provides advanced data analysis, implementation and maintenance of effective Statistical Process Control (SPC) programs across the biologics network at BMS (internal and Third Party Manufacturing sites). The candidate will interact with the different parts of the Biologics Development organization, and all Biologics Manufacturing sites.

Duties/Responsibilities:

• Provide multivariate analysis (MVA) modeling for improved process understanding and robustness.
• Partner with laboratory groups and MT to build capability using new technologies (e.g. metabolomics, proteomics, Umetrics, and PAT) to gather and analyze process data to drive yield improvements and process robustness.
• Support the MS&T book of work including experimental design, statistical training and advanced analysis of complex datasets to support next generation process development, technical transfers and process improvements.
• Support AS&T and Quality Control activities related to building and sustaining a method performance and stability monitoring program.
• Support the AS&T book of work including comparability assessment for drug substance and drug product technical transfers, next generation process development, 2-tiered reference standard implementation, and new method introduction.
• Support MS&T Materials Sciences groups to identify raw material data requirements, work with vendors to ensure supply of relevant raw material data, and incorporate into Discoverant and MVA modeling.
• Support Facilities and Engineering to develop and report Equipment Robustness metrics.
• Support the development of dashboards and automated reporting capabilities for process and product robustness.

Qualifications
QUALIFICATIONS

• Minimum BS or equivalent with 9 years BMS/ relevant experience, MS or equivalent with 6 years BMS/ relevant experience, Ph.D. level in Scientific or Mathematical discipline with 0+ years of relevant experience.
• Knowledge of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
• Knowledge of biopharmaceutical facility design, process design and optimization, and manufacturing operations.
• Excellent verbal & written communications skills.
• Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization.
• Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility.
• Proven leadership skills with ability to direct and influence a team.
• Demonstrated problem solving ability, attention to detail, and analytical thinking.
• Significant experience in statistical analysis is highly desired.
• Experience with the use of and scripting in different software packages like Matlab, SAS, JMP, Minitab, Umetrics SIMCA, and Accelyrs Discoverant is an advantage. Experience with data management systems and data networks is preferred.

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