Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA

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. 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.

A Specialist, Lead Manufacturing Associate, Cell Therapy performs a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

BMS Values

• Our values move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
• Candidates must exemplify the BMS values of Passion, Integrity, Inclusion, Accountability, Innovation, and Urgency:
  • Passion
    • Leads by example and drives their team to adhere to the BMS values
    • Technical proficiency in all operations
    • Eliminate tribal knowledge
    • Matrix leader, operational coach and mentor
    • Provide real-time feedback to associates during production activities
    • Support development goals for peers
    • Celebrate team successes
  • Urgency
    • Influence interim controls
    • Resolve issues at local level and escalates when appropriate
    • Supports team by removing bottlenecks when necessary
    • Anticipate deadlines and challenges
    • Escalates and facilitates decision-making
    • Delegate tasks, as necessary
  • Innovation
    • Responsible for work innovations. Be the champion for continuous improvement.
    • Functional representative on projects
    • Acknowledge ideas and /or issues with feedback on path forward
  • Accountability
    • Encourages accountability and right-first-time execution
    • Be purposefully present in the work area
    • Accurately convey process issues and status of production
    • Drive execution of daily tasks to ensure schedule adherence
    • Prioritize and maintain off the floor commitments (outlook schedule)
    • Maintain training compliance
    • Take personal responsibility to work safely and ensure colleagues do the same
  • Integrity
    • Demonstrate integrity and influences others to act with integrity
  • Inclusion
    • Leads with empathy while maintaining team accountability
    • Collaborate with cross-functional partners to facilitate problem-solving
    • Contribute to a positive culture for the team and functional area
    • Leverage personal relationships to align team goals
    • Set KIND standards
    • Maintain and support a collaborative environment

Shifts Available:

A2, 6pm - 6am, rotating days including holidays and weekends

Responsibilities:

• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Executes transactions and process in all electronic systems
• Demonstrate a strong practical and theoretical knowledge in their work
• Complete documentation required by governing controlled documents and batch records. Ensure that all documentation produced by their team is right first time.
• Solve complex problems; takes new perspectives using existing solutions
• Easily approachable and maintains a desire to build and foster relationships while working through challenges/opportunities.
• Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Evaluate team processing performance and communicate delays to leadership. Takes a proactive approach in resolving issues / bottlenecks.
• Complete training assignments to ensure the necessary technical skills and knowledge
• Proficient in process systems and supporting business systems
• Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
• Collaborate with support groups on recommendations and solving technical problems.
• Ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule
• Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
• Initiates deviations and supports investigations / CAPA development
• Qualified as a deviation investigator and completes assigned investigations timely
• Completes change actions for change controls or investigations
• Initiates and facilitates triage calls, provides support to Management as needed
• Identify and propose innovative solutions
• Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Trains and qualifies others on SOPs, Work Instructions to successfully complete manufacturing operations
• Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
• Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
• Aid in daily work coordination and distribution as demanded through the production schedule
• Maintain schedule adherence and cycle time. Report variances and communicate impact to cross functional groups and managers
• Provide shift handover, as needed
• Ensure shift notes communication is complete and accurate, as needed
• Provide daily update summary to functional group for SQDCP, as needed
• 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 processes (as assigned) as operator / verifier
• Leads cross-functional projects and ensure timelines and deliverables are adhered to
• Attends Leadership Development training as development opportunity for career path as a future people leader
• Shadows manager(s) on leadership tasks in preparation for potential future responsibilities (including but not limited to, preparing production schedule, running team meetings, providing technical feedback to colleagues, giving recognition when deserved)

Knowledge and Skills:

• Extensive knowledge of cGMP regulations and FDA guidance applicable to 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 processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Cell expansion using incubators and single use bioreactors

Basic Requirements:

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

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, 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 / 15 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)

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.

BMSCART

#LI-ONSITE

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 a supportive culture, promoting global participation 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 an 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.

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/

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