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Bristol Myers Squibb

Senior Specialist, Process Engineer II

Equipment/Technology Specialist

Equipment and Facilities Specialist

No

Summit, New Jersey, United States

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.

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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

PURPOSE AND SCOPE OF POSITION:

The Senior Specialist, Process Engineer II is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Serves as process SME. Collaborates with SME from the Development 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 of cGMP’s and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus
  • 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

Education and Experience:

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

DUTIES AND RESPONSIBILITIES:

  • Participate on project teams to 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)
  • Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
  • 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
  • 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
  • Participate in routine plant operating meetings
  • S12 is a 24/7 CAR T manufacturing site and this position may require night / weekend rotational work hours

WORKING CONDITIONS (US Only):

  • The incumbent will be working 60% to 75% of the time in an office environment.
  • The incumbent will be working 25% to 40% of the time in a manufacturing and/or laboratory setting.
  • The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
  • The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
  • The incumbent may be required to work night shift on a long term schedule.

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.

Why You Should Apply:

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.

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 accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

VETERAN

#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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.