Senior Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations • Value Stream CAR-T Manufacturing

Bristol-Myers Squibb Company; Summit (NJ); On-site; USD 41,000 - 51,000; Full time

Benefits offered by this job

Wellbeing support

Flexible Time Off

11 paid holidays

Stock opportunities

Job summary

Bristol Myers Squibb is seeking a Senior Manufacturing Associate for its cell therapy manufacturing in Summit, NJ. The role performs operations in a cGMP cleanroom under supervision, adhering to SOPs, batch records and quality systems, with potential team lead duties and cross-functional collaboration.

Ideal candidates have 3+ years in cGMP cell therapy manufacturing, strong knowledge of GMP regulations, and experience training others.

Qualifications

• High school diploma or equivalent required; higher degree preferred.
• 3+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or related experience.

Responsibilities

• Execute operations per SOPs, work instructions, batch records and forms.
• Maintain compliance with GMP, safety and quality systems; participate in investigations as needed.
• Train others on Source Governing Documents and processes to ensure proficiency.
• Complete documentation contemporaneously; assist with deviations and change impact assessments.

Skills

cGMP knowledge

Floor leadership

Engineering principles

Office tools

Interpersonal skills

Professional relationships

Cell therapy manufacturing

Trainer experience

Education

High school diploma

Associate/Bachelor's degree preferred

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 Senior Manufacturing Associate manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Shift Available:

Quad 3 Wednesday - Saturday (with every other Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m.

Responsibilities:

• Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) compliantly
• Executes transactions and process in all electronic systems and adheres to business continuity procedures
• Role models and leaders for the culture of compliance, safety, and team dynamics
• Controlled document & Deviation authoring, change impact assessment and action owner
• Demonstrate a strong practical and theoretical knowledge in their work
• Can represent department in cross-functional department collaborations
• May be assigned Team Lead duties as needed / delegated
• Complete documentation required by Source Governing Documents contemporaneously
• Solve complex technical problems; takes new perspectives using existing solutions
• Perform all tasks in a manner consistent with the safety policies, Source Governing Documents, Quality Systems, and GMP requirements including ALCOA+
• Complete training assignments prior to assigned due date to ensure the necessary technical skills and knowledge
• Trains for proficiency in process systems and some supporting business systems, and maintains trainer qualifications
• Train others on Source Governing Documents to successfully complete manufacturing operations
• Identify and propose innovative solutions
• Continues to refine and improve manufacturing process technique and improve individual operational times.
• Work within a controlled cleanroom environment and perform aseptic processing (as assigned; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
• Cross-trained into multiple manufacturing processes (as assigned)
• Verifies training completion prior to performing any GxP tasks

Knowledge & Skills:

• Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired
• Demonstrated aptitude for engineering principles and manufacturing systems
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications
• Demonstrated good interpersonal skills, is attentive and approachable
• Maintain a professional and productive relationship with area management and co-workers
• Experience in cell therapy manufacturing, including Cell washing, Cell Expansion processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Experience as a trainer

Minimum Requirements:

A minimum high school diploma and/or equivalent combination of education and experience is required. Associate or bachelor's degree in related field is preferred. 3+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Working Conditions:

• Must be able to stand/walk for extended periods of time
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection
• Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
• Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
• Work in areas that may have strong magnets
• Must be able to work in a BSL2 / ML1 work environment handling human blood components
• Work in areas with exposure to vapor phase liquid nitrogen
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Summit West - NJ - US: $30.61 - $37.09per hour The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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 [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.