Manager - Process Monitoring Lead (R1556363-en-us-1)
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 Manager - Process Monitoring Lead within Manufacturing Sciences & Technology will be responsible for Continued Process Verification (CPV) and robustness for the commercial products manufactured in BMS and third-party manufacturing sites. The role will interact with personnel at various BMS locations and is responsible for leading and reporting product robustness for Pharma drug substance, drug product, and packaging manufacturing. The group performs statistical analysis/trending of critical data, generates reports, prepares and presents analysis in robustness meetings, and maintains an effective Robustness program across the Pharma network at BMS (internal and Third Party Manufacturing sites). The PML will interact with the different parts of the Global Pharmaceutical Development, Quality Assurance, and Supply Chain organization.
- Manage the implementation of structures, tools, and processes to manage CPV across the BMS Pharma portfolio actively. Support data collection for several products/product families and sites from multiple platforms such as SAP, LIMS, and Discoverant.
- Performs analysis and trending of data using process control capability chart and other statistical tools. Manage and support investigations resulting from quality events, robustness trends, and statistical outliers.
- Manage and support inquiries from regulatory agencies and matrix teams using data systems (LIMS, Data Lake, spreadsheets)
- Contribute to issuing CPV plans, reports, and other documents required by regulatory agencies.
- Conducts data reviews and knowledge sharing sessions across the organization in collaboration with MS&T, sites, and CMOs.
- Supports the MS&T book of work, including data collection automation and advanced analysis of complex datasets to support continuous improvement and product transfers.
- Support the development of dashboards and automated reporting capabilities for process and product robustness
- Provides statistical analysis using statistical packages like JMP, Minitab, and Excel.
- Demonstrates a strong knowledge of cGMP compliance, regulatory requirements, and procedures and incorporates them into assigned projects.
- Experience in the pharmaceutical industry with knowledge of solid oral dose manufacturing operations is required. Experience managing validation data or CPV programs is a plus.
- Excellent verbal & written communications skills. Interpersonal/facilitation skills are necessary to interface with and influence all levels of the organization.
- Proficiency with MS Office, especially Excel, Word, and PowerPoint, is a must. Experience with data management systems and data networks is a plus.
- Knowledge of statistical analysis is highly desired, and experience using statistical software JMP/Minitab is required.
- Demonstrated ability to take the initiative, prioritize objectives from multiple projects, and adhere to scheduled timelines while maintaining flexibility
- Proven leadership skills with the ability to direct and influence a team
- Demonstrated problem-solving ability, attention to detail, and analytical thinking
- Experience with data analytics and statistical programming languages like R, Python, SAS, or similar is a plus.
Minimum BS or equivalent in Engineering, Industrial Pharmacy or related fields with 6 years BMS/ relevant experience, MS or equivalent with 4 years of relevant experience, Ph.D. level in Scientific or Mathematical discipline.
This position might require up to 10% of travel
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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