Job Details
NIGHTS, Specialist, Lead Manufacturing Associate, Cell Therapy
Working with Us
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
Position Summary:
Serve as a lead associate in the manufacture of human blood derived components per Batch Records and Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment. Lead Manufacturing Associate adheres to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Support the quad manager for communication of production deviations, review of executed batch records and assistance with quality investigations are required, as applicable. The Lead Manufacturing Associate works closely with the Quad Manager and serves to supervise the shift when the manager is not available. The Lead Manufacturing Associate is also a qualified trainer for all buckets of operation.
Required Competencies:
- Thorough understanding of media production (if applicable), cell culture, selection/isolation, activation/initiation, transduction, debead (if applicable), expansion, harvest and cryopreservation for CAR-T
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Basic mathematical skills
- Full compliance with Good Documentation Practices
- Technical writing capability
- Proficient in MS Office applications
- Proficient in BMS Business Applications including Syncade/MES/Oracle, EQRMS/Infinity, Cellabs
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Experience in any of the following areas is required: (Aseptic processing in ISO 5 biosafety cabinets, Universal precautions for handling human derived materials in BSL-2 containment areas, Cell expansion using incubators and single use bioreactors, Cell washing processes and automated equipment, Cell separation techniques and automated equipment, OR Cryopreservation processes and equipment)
- Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays)
- Experience as a trainer for GMP manufacturing processes
Key Responsibilities:
- Production of blood component lots for one CAR-T bucket of operations
- Cross trained in all other buckets of operations (based on availability and business need)
- Provide training and guidance to manufacturing associates as required.
- Aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
- Aseptic qualification required per bucket
- Weigh and measure in-process materials to ensure proper quantities are added/removed.
- Perform and oversee process unit operations described in standard operating procedures and batch records.
- Complete and review documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Assist Manager to ensure the shift performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Serve as a qualified trainer to maintain the shift at an acceptable qualification standard.
- Support deviation investigations and on-time closure of deviations and CAPAs.
- Work with Manager to schedule daily unit operations that includes people, product, and material flow across multiple shifts.
- Ensure associates execute scheduled activities on-time, in accordance with the production schedule.
- Ensure the batch records for production data and all information are in a clear, concise, format according to proper GDPs.
- Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.
- Collaborates closely with Managers to ensure seamless pass down and communication of operational status.
- Other duties may be assigned, as necessary.
- No direct reports will be assigned to this job role.
Qualifications & Experience:
- Master's Degree and 2 years of Manufacturing or Operations Experience
- or bachelor’s degree and 4 years of Manufacturing or Operations experience
- or Associate/ Medical Technical degree and 8 years of Manufacturing or Operations experience
- or High School diploma/GED and 10 years of Manufacturing or Operations experience.
Working Conditions:
- Intermittent walking, standing and sitting to perform job functions; however, ability to stand for extended periods of time may be necessary.
- Must be comfortable working with contained human blood components.
- Physical dexterity sufficient to use computers and documentation.
- Sufficient vision and hearing capability to work in job environment.
- Ability to lift 25 pounds.
- Must have the ability to work in laboratories and controlled, enclosed, restricted areas.
- Must be able to be near strong magnets
- Must be comfortable being exposed to human blood components.
- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
- Makeup, gum, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
- Reagents, chemicals, and exposure to sanitization agents are expected.
- Routine exposure to human blood components.
- Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.
- Work from home is not approved for this role
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.
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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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
COVID-19 Information
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.
BMS is dedicated to ensuring that people with disabilities can perform complex functions 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 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 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.