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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

Title: Engineer I, CAR-T Clinical Manufacturing Sciences & Technology

Location: Warren, NJ

At Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Engineer I, CAR-T Clinical Manufacturing Sciences & Technology 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.

Qualifications & 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)

• 5 or more years of manufacturing support or related experience in the biopharmaceutical industry

• Intermediate knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations

• Intermediate knowledge of facility/clean room design, process, equipment, automation, and validation

• Beginner knowledge of Delta V and OSI Pi

• 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

• Intermediate knowledge of quality by design and risk management

• Intermediate experience with Operational Excellence and Lean Manufacturing

Key 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

WORKING CONDITIONS: (US Only)

A. 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.

B. ENVIRONMENTAL CONDITIONS:

• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

C. WORK HOURS:

• This job position will have to prioritize work outside typical business hours (after 5pm EST) and will have to prioritize weekend work when necessary.

• When weekend work is heavy, employee can support 4-day, 10-hr/day from Friday thru Monday to satisfy work hours for the week.

• When night work and weekend work is minimal, employee can support typical 5-day, 8-hr/day from Monday thru Friday to satisfy work hours for the week.

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.

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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in 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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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.

Company: Bristol-Myers Squibb

Req Number: R1582951

Updated: 2024-06-29 04:19:35.088 UTC

Location: Warren-NJ

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.