Process Engineer I CAR-T Project Support

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary:

Process Engineer I, CAR-T Project Support CAR-T Process Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Manages multidiscipline projects, creation/revision of engineering documentation and management of external resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products for both global clinical trials and commercial supply. Collaborates with SME from the Development Group, Manufacturing Group, and Quality Group while running cross functional internal project teams from initiation through project closeout (e.g. he/she is the primary internal and external contact regarding the day-to-day execution of the project) in support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities include, but are not limited to, the following:


Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
Run internal projects (e.g. Project initiation, planning, scope, funding requests, approvals, execution and closeout)
Direct multidisciplinary project teams to ensure delivery of the project on time, on budget and to pre-defined quality level. Prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate progress, risks and status to project stakeholders and senior management
Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
Sponsor and support the change initiatives and the implementation of process improvement initiatives
Foster strong inter-team relationships to achieve common project goals
Interface with operations and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production
Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities
Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations
Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
Interact with other teams including Validation, Development, Operations, QA and Regulatory
Support Director in accomplishing productivity and financial goals with the cross-functional team
Support the tracking of team metrics and manage completion of objectives and projects
Participate in routine plant operating meetings


Leadership:


Create an environment of teamwork, open communication, and a sense of urgency
Support the change agent in promoting flexibility, creativity, and accountability
Support organizational strategic goals and objectives that are linked to the overall company strategy
Drive strong collaboration within the plant and across the network
Build trust and effective relationships with peers and stakeholders
Deliver business results through timely and quality decision making and advice
Foster a culture of compliance and strong environmental, health, and safety performance
Promote a mindset of continuous improvement, problem solving, and prevention


Prerequisites:


Experience in biologic/vaccine manufacturing support, tech transfer, and validation


Skills/Knowledge Required :


Expert knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations
Deep knowledge of facility/clean room design, process, equipment, automation, and validation
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
Experience working with external parties and/or leading cross-functional teams
Possess strong verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Experience with Operational Excellence and Lean Manufacturing
Bachelor's Degree required (science or engineering is preferred)
3 or more years of manufacturing support or related experience in the biopharmaceutical industry


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.

Company: Bristol-Myers Squibb

Req Number: R1520463_EN

Updated: 2020-01-30 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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