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Specialist, Manufacturing Technical Development

Bristol Myers Squibb Summit West - NJ - US Full-time
$72,090
per year

Job Description

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. 

 

Specialist, Manufacturing Technical Development is responsible for the successful implementation of the site Manufacturing Training ProgramThe Specialist develops and administers training solutions that adhere to the Site Training Program.  This position trains other staff members, as well as assesses their ability to perform tasks proficiently.  The Specialist may also perform cleanroom processing duties as a Manufacturing Associate as needed.  

 

Shift Available: 

  • Monday - Friday, Onsite Day Shift, 7:00 a.m. - 3:30 p.m. 

 

Responsibilities: 

  • Implements training programs that meet regulatory requirements & business needs including: 

  • Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.  

  • Works with the Manager on an on-going basis to implement training goals and meet KPI’s. 

  • Conducts ILT and OJT sessions to ensure cleanroom operators are proficient. 

  • Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training. 

  • Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities. 

  • Collaborates with the Manager to ensure training is compliant and effective. 

  • Maintains accurate training documentation and employee record keeping. 

  • Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement. 

  • Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary. 

  • Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.  

  • Develops / implements new course content as procedures change or as new techniques are introduced. 

  • Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.  

  • Implements the local Manufacturing Operations new hire Training Program including: 

  • Promotes and exhibit core BMS values in onboarding and training activities. 

  • Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements. 

  • Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation. 

  • Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training. 

  • Communicates with different departments to ensure new hires have access to all necessary systems and security. 

  • Maintains the training status of new hires and communicates progress to Department Management. 

  • Maintain the Training Laboratory and equipment for cleanliness and compliance. 

  • Complete room activity, maintenance, cleaning, and equipment usage logs (as required).   

  • Run daily calibration checks on equipment where appropriate and escalate deviations. 

  • Perform routine cleaning of laboratory areas and equipment. 

  • Ensure sufficient laboratory supplies for daily training activities.   

  • Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed): 

  • Execute/Implement batch records in ISO 7 & 8 clean room environments. 

  • Observe, practice, and promote all aspects of the GMP & GDP requirements. 

  • Complete and maintain aseptic processing and sterile gowning qualifications.  

  • Communicate with Quality Control to ensure proper handoff of process samples. 

  • Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.   

  • Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.   

  • Reports and initiates non-conformances and participate in follow up investigation when necessary. 

  

Knowledge & Skills: 

  • Requires a high level of understanding of cell therapy processes, controls, and GMP requirements. 

  • Intermediate skills in design, development, and implementation of training. 

  • Advanced skills in using Microsoft Word, PowerPoint and Excel.  

  • Requires a high level of organizational and time management skills. 

  • Ability to communicate information clearly to facilitate effective learningThis position requires speaking in classroom settings. 

  • Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts. 

  • Ability to work in an aseptic environment requiring successful completion of qualification program. 

 

Basic Requirements: 

  • B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline. An equivalent combination of working experience and education will be considered.

  • Must have hands-on training experience.

  • Must be qualified in 2 or more manufacturing functional areas. 

  • Must be Aseptic qualified and ISO 7 gowning qualified.

  • A minimum of 4 years of relevant experience in the manufacturing pharmaceutical industry.

 

Preferred Requirements: 

  • Understands training cadence of each bucket and associated curriculum structures. 

  • Conducts training sessions and workshops for new hires and existing employees. 

  •  CELABs experience. 

The starting compensation for this job is a range from $72,090 to $87,400 plus incentive cash and stock opportunities (based on eligibility). 

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 
Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

BMSCART, #LI-Onsite

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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 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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company Information

Location: New York, NY

Type: Hybrid