Engineer I, CAR T Clinical 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.

PURPOSE AND SCOPE OF POSITION:

The Manufacturing Sciences and Technology Engineer Clinical CAR-T Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs from the Development Group, Global MSAT Group, Supply Chain Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

Basic knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations

• Basic knowledge of facility/clean room design, process, equipment, automation, and validation
• Intermediate strong verbal/written communication skills and ability to influence at all levels
• Intermediate ability to think strategically and to translate strategy into actions
• Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Basic knowledge of quality by design and risk management
• Basic experience with Operational Excellence and Lean Manufacturing

DUTIES AND RESPONSIBILITIES:

Ensure safe and compliant cGMP operations;

• Maintain permanent inspection readiness and actively support regulatory inspections.
• Interface with regulatory authorities as required to support Manufacturing Operations audits.
• Foster a culture of compliance and strong environmental, health, and safety performance.
• Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• 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)
• Sponsor and support the change initiatives and the implementation of process improvement initiatives

Support Clinical Production Activities;

• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Continuously monitor, anticipate and permanently resolve issues that may arise during production.
• Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
• Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
• Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
• 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

Display Leadership Qualities;

• 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 results through timely and quality decision making and advice
• Promote a mindset of continuous improvement, problem solving, and prevention
• Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management

EDUCATION AND EXPERIENCE:

• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Bachelor’s Degree required in Engineering or Related Discipline (advanced degree is preferred)
• Two or more years of manufacturing support or related experience in the biopharmaceutical industry

WORKING CONDITIONS: (US Only)

PHYSICAL /MENTAL DEMANDS:

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.

ENVIRONMENTAL CONDITIONS:

Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.

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