Principal Engineer , Operational Excellence, Cell Therapy Global Manufacturing Sciences and Technology
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 CAR-T Global External Manufacturing Science and Technology Principal Process Engineer role leads efforts that focus on improving and optimizing manufacturing and supply chain processes at several external manufacturing sites around the world that are producing personalized cell therapy products used for both global clinical trials and commercial supply. This position contains aspects of Operational Excellence including Lean Six Sigma tools and approaches to complex problem solving and continuous improvement opportunities to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. It also contains aspects of Production Support Engineering including complex investigational support, root cause analysis, technical troubleshooting, new process startups, capacity expansions, and local change implementations. This position is a highly cross functional support role on global technical support team with a focus on cell therapy manufacturing operations. It collaborates with a wide variety of functions and sites across the BMS Cell Therapy Operations (CTO) network as well as representatives from external third-party manufacturers. This position is a management position with 1 or more direct reports.
Charter operational improvement opportunities and implement assigned changes using appropriate GMP change management processes. Develop project timelines, resource estimates, and ROI
Develop simulated process models to estimate throughput capacity, resources, inventory levels while testing What If scenarios for process optimization.
Provide data analysis and interpretation on manufacturing and manufacturing support processes. Determine areas of opportunity, shifts and trends, and states of control
Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations when needed.
Support manufacturing sites to create and revise technical documentation (e.g. changes controls, SOPs, and batch records)
Support validation and startup activities that may include providing process training to support implementation of new technologies and specifications as well as process changes.
Support deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenging deviations and drive them towards closure.
Support development and tracking of team and VPT metrics and manage completion of objectives and projects.
Deliver communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
Foster innovative behaviors and strong inter-team relationships to achieve improvement goals.
Participate in GMSAT learning and sharing events. Participate in external learning and training events related to Cell and Gene Therapy industry and related manufacturing topics.
Qualifications & Experience
Minimum a bachelor’s degree in engineering or life science from an accredited college or university is required (preferred specialties are: Industrial, Biomedical, Chemical, or Mechanical) and 7+ years of relevant experience
Candidates must be comfortable and well-versed working in an online computer-based environment as vast majority of work is performed remotely across time zones. Onsite presence is required at either Seattle or New Jersey BMS office locations with up to 50% remote work from allowed with direct manager approval.
Extensive experience in a regulated (GMP) manufacturing environment
Lean Six Sigma qualifications with an established track record of Operational Excellence project implementation (Green Belt minimum)
Experience or knowledge of statistical analysis using statistical software package. Examples include JMP, Minitab, R
Technical writing skills with ability to author peer reviewed protocols and reports, production batch records, standard operating procedures
Experience or knowledge of creating computer-based process models using process simulation software. Examples include Simio, eVSM, Spreadsheet Models.
Ability to assess risk and develop contingency plans for process risks
Experience with process validation is strongly preferred
Cell therapy experience preferred
Excellent communication, writing, organizational, teamwork, and presentation skills
Strong interpersonal and leadership skills to work with teams in different functions and organizations
Ability to travel domestically and internationally, typically less than 5% of time.
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies preferred
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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