Specialist, Manufacturing Technical Development

Bristol Myers Squibb; Summit (NJ); On-site; USD 52,000 - 63,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

11 paid holidays

Stock opportunities

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Specialist, Manufacturing Technical Development to lead the site Manufacturing Training Program and ensure compliant training for staff in aseptic processes.

The role trains staff, develops and administers training solutions, performs ILT/OJT sessions, and collaborates with management and Quality to drive continuous improvement while maintaining cGMP and regulatory standards.

Qualifications

• Bachelor's degree in Biology, Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or a related field.
• At least 4 years in a cGMP-regulated biopharmaceutical, biotechnology or pharmaceutical manufacturing environment.
• At least 4 years in cell therapy manufacturing processes and GMP regulations.
• At least 2 years delivering training programs in a regulated environment.
• Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Strong organizational, project and time management skills.

Responsibilities

• Implements training programs meeting regulatory requirements and business needs.
• Works with management to create a training plan addressing production demands.
• Conducts ILT and OJT sessions for aseptic processing.
• Provides trainee feedback and identifies gaps requiring additional training.
• Maintains training documentation and records.

Skills

Communication skills

Classroom teaching

Interpersonal skills

Aseptic environment

Documentation

Training program design

Cross-department collaboration

Education

Bachelor's degree in Biology or related field

Tools

Microsoft Office

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.

Specialist, Manufacturing Technical Development is responsible for the successful implementation of the site Manufacturing Training Program. The 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

• Q1: Sunday - Wednesday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 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.

Knowledge & Skills

• Collaborates with the Manager to ensure training is compliant and effective.
• Ability to communicate information clearly to facilitate effective learning. This 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 a qualification program.
• 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 elevate deviations.
• Perform routine cleaning of laboratory areas and equipment.
• Ensure sufficient laboratory supplies for daily training activities.

Minimum Requirements

• Bachelor's degree in Biology, Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or a related scientific or engineering field.
• At least 4 years of experience in a cGMP-regulated biopharmaceutical, biotechnology, or pharmaceutical manufacturing environment.
• At least 4 years of experience with cell therapy manufacturing processes, associated controls, and GMP regulations.
• At least 2 years of experience in the design, development, implementation, and delivery of training programs within a regulated environment.
• Advanced proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Demonstrated organizational, project management, and time management skills, with the ability to effectively prioritize competing priorities and meet deadlines.

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: $38.12 - $46.20per 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.

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.