Specialist, Training and Development

Position Summary

Specialist, Manufacturing Technical Development is responsible for implementing the site Manufacturing Training Program. Develops and administers training solutions aligned with the Site Training Program, trains staff, and assesses task proficiency. May perform cleanroom processing duties as a Manufacturing Associate as needed.

• Implement training programs meeting regulatory requirements and business needs.
• Create and execute training/development plans to meet production demands and KPIs.
• Conduct ILT and OJT sessions to ensure cleanroom operator proficiency.
• Provide trainee feedback and identify skill/knowledge gaps requiring additional training.
• Solicit trainee feedback for course appropriateness and continuous improvement.
• Maintain training documentation and accurate employee record keeping.
• Develop/implement course content, procedures, SOPs, and TRNs as needed; update based on trends and procedure changes.
• Perform ongoing competency assessments of operators.
• Implement new hire training (schedule, supplies, enrollment, documentation; ITL/OJT on aseptic processing and GMP; coordinate system/security access; track and report training status).
• Maintain training laboratory cleanliness/compliance; perform room logs, equipment calibration checks, routine cleaning, and ensure supplies.
• As needed: execute batch records in ISO 7 & 8; follow GMP & GDP; maintain aseptic processing/sterile gowning qualifications; handoff samples with Quality Control; elevate safety/product quality issues; support process improvements; initiate non-conformances.

• High understanding of cell therapy processes, controls, and GMP; strong organizational/time management.
• Intermediate training design/development/implementation skills.
• Advanced MS Word/PowerPoint/Excel.
• Clear communication for classroom instruction; strong interpersonal skills.
• Ability to work in aseptic environment and complete qualification program.
• B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering (or related) plus 4-5+ years in clinical laboratory or blood/cell culture processing.

Summit West - NJ - US: $38.12 - $46.20 per hour.