Manager, Engineer, Process Monitoring and Analytics

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.

The Engineer in the Process Monitoring and Analytics (PMA) group within Manufacturing Sciences & Technology will be responsible for product robustness of the commercial products manufactured in BMS and contract manufacturing organizations (CMO). The PMA team provides advanced data analysis and reporting to ensure robust manufacturing process and product quality. The team is responsible for the implementation and maintenance of procedures, systems, and business processes related to Continued Process Verification and product robustness programs across the BMS network (internal and CMO sites). The candidate will interact with the different parts of the Global Product Development and Supply organization at the network and site-level.

Duties & Responsibilities

• Provides support to maintain the Statistical Process Control (SPC) program, manufacturing performance trending and reporting.
• Manage and support investigations as a result of robustness events and SPC trending
• Provides system administration/maintenance of the data trending electronic systems such as Discoverant.
• Manage and support data inquiries from regulatory agencies and matrix teams using data systems (LIMS, Discoverant, Datas Lake)
• Provides data and analysis for regulatory inspections and other interactions with regulatory agencies as required.
• Demonstrates a strong knowledge of cGMP compliance, regulatory agency requirements and procedures and incorporate into all assigned projects.
• Manages the implementation of process or equipment changes as a result of the SPC program.
• Support the development of dashboards and automated reporting capabilities for process and product robustness
• Provide statistical analysis on complex datasets using statistical packages (JMP, Minitab) and/or coding (R/Python)
• Partner with laboratory groups and MT to build capability using new technologies (e.g Umetrics, and PAT) to gather and analyze process data to drive yield improvements and process robustness

Qualifications

• Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment
• Knowledge of pharmaceutical facility design, process design and optimization, and manufacturing operations
• Knowledge of aseptic fill finish, sterile manufacturing, and parenteral packaging.
• 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
• Experience in statistical analysis is highly desired
• Experience with the use of and scripting in different software packages like SAS, JMP, Minitab, Spotfire, Umetrics SIMCA, and Discoverant is an advantage. Experience with data management systems and data networks is preferred.
• Experience with data analytics and the use of statistical programming languages like R, Python, SAS is preferred

#LI-Onsite

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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