Specialist, Engineer I

Celgene • Summit, NJ

38d • Hybrid

About The Position

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. 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. 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. This role is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Potential areas of responsibility include providing day-to-day manufacturing support during and after business hours as needed, leading manufacturing investigations pertaining to the process control strategy and associated elements, managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability, managing CPV and process monitoring program, and support development and lifecycle management of MBR and EBR. These areas include creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) required to support the production of personalized cell therapy products. Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization. Shift Available: Sunday - Wednesday, Hybrid Overnight Shift, 5 p.m. - 5 a.m.

Requirements

• Bachelor's Degree required (science or engineering is preferred).
• 1 year of relevant experience within a manufacturing GMP facility.
• Technical Writing skills.
• Knowledge of cGMPs and multi-national biopharmaceutical regulations.
• Must have excellent organization skills and ability to handle multiple tasks.
• 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.

Nice To Haves

• Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control.
• Proven delivery of complex investigation reports.
• Cell therapy experience is a major plus.
• Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus

Responsibilities

• Provide remote process support for ongoing manufacturing activities when needed.
• Ability to provide floor process support in exception cases.
• Interface with Manufacturing operations and QA Shopfloor and serve as process SME.
• Lead product impact assessments to support investigations.
• Support lifecycle management project implementation at a site level to accomplish drug product harmonization across sites and evolve process.
• Support the change initiatives and the implementation of process improvement initiatives.
• Foster strong inter-team relationships to achieve common project goals.
• Support process monitoring initiatives including but not limited to developing and collecting data.
• Analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production.
• Execute test plans, change controls, and other risk mitigation exercises 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
• Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).
• Interact with other teams including Technical Product Team, Validation, Development, Operations, QA and Regulatory.
• Participate in routine plant operating meetings (i.e. Tiers, Townhalls, MSAT Extended Staff, etc.).
• Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.
• Ability to set priorities, manage timelines and effectively react/manage changing priorities.
• Ability to work with management (global and site) and support corporate and departmental goals.
• Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees