Cell Therapy Manufacturing Training Specialist

Bristol-Myers Squibb Co; United States; On-site; USD 52,000 - 63,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Volunteer days

Job summary

Bristol-Myers Squibb is seeking a Specialist, Manufacturing Technical Development to design and administer the site Manufacturing Training Program. You will train staff, assess proficiency, and may perform cleanroom tasks as needed, supporting manufacturing operations at SummitWest, NJ.

The role requires a biology/engineering background with experience in cell therapy manufacturing, regulatory training, and strong communication.

Qualifications

• Bachelor's degree in Biology, Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related 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 Word, Excel, and PowerPoint.
• Demonstrated organizational, project management, and time management skills, with the ability to effectively prioritize competing priorities and meet deadlines.

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.
• 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.

Skills

Strong interpersonal skills

Facilitation

Aseptic training

Training program design

ILT/OJT training

Regulatory compliance

Education

Bachelor's degree in Biology, Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Bristol-Myers Squibb is seeking a Specialist, Manufacturing Technical Development to design and administer the site Manufacturing Training Program. You will train staff, assess proficiency, and may perform cleanroom tasks as needed, supporting manufacturing operations at SummitWest, NJ.

The role requires a biology/engineering background with experience in cell therapy manufacturing, regulatory training, and strong communication.