Specialist, Training and Development

Scorpion Therapeutics; Summit (NJ); On-site; USD 52,000 - 63,000; Full time

Job summary

Scorpion Therapeutics in Summit, NJ is seeking a Specialist, Manufacturing Technical Development to implement the site Manufacturing Training Program, develop and administer training solutions, train staff and assess task proficiency. May perform cleanroom processing duties as needed.

Responsibilities include implementing training programs that meet regulatory requirements, creating development plans to meet production KPIs, conducting ILT and OJT sessions, providing trainee feedback,

Qualifications

• BS in Biology, Biochemical, Chemical, or Biomedical Engineering (or related) with 4–5+ years in clinical laboratory or blood/cell culture processing.
• Strong understanding of cell therapy processes and GMP; good organizational/time management.
• Clear communication for classroom instruction; ability to work in aseptic environments.

Responsibilities

• 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.
• Maintain training documentation and accurate employee records.
• Develop/implement course content, procedures, SOPs, and TRNs; update as needed.
• Perform ongoing competency assessments of operators.
• Maintain training lab cleanliness and compliance; perform room logs and routine cleaning.

Skills

Cell therapy

GMP knowledge

Training design

Communication

Aseptic processing

Education

BS in Biology/Engineering

Tools

MS Word

PowerPoint

Excel

Job description

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.

Duties/Responsibilities

• 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.

Qualifications

• 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.

Compensation

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