Aseptic Manufacturing Specialist — GMP Leader

Alcami-5; Morrisville (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Alcami is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug product production, participate in continued process verification, and train staff across departments. The role requires leadership, data analysis, and GMP compliance to ensure robust manufacturing for commercial and clinical programs.

The position is 100% on-site with a 1st shift (Mon-Fri, 8:00am-4:30pm) and up to 5% travel.

Qualifications

• Bachelor’s degree preferred with 2+ years sterile injectable manufacturing experience.
• Or high school diploma with 8+ years sterile injectable manufacturing experience.
• Minimum 1 year of experience in technical writing (deviations, SOPs, batch records).

Responsibilities

• Perform data analysis and trending of manufacturing processes to spot improvements.
• Measure unit operation durations to optimize scheduling for facility/client needs.
• Author Change Controls for investigations and process changes.
• Author investigations and drive timely closure.
• Review and approve new batch records and review executed batches.
• Train manufacturing staff on SOPs, batch records, and GMP rationale.
• Provide floor support for commercial, clinical, and validated processes.
• Act as SME for clients/stakeholders on product types.
• Assess product impact of excursions outside acceptable ranges.
• Identify opportunities to improve process performance within equipment limits.
• Troubleshoot unexpected cGMP events and document CAPAs.
• Comply with FDA/EPA/OSHA/DEA and company policies.

Skills

Data analysis

Leadership

Training

Troubleshooting

GMP knowledge

Technical writing

Education

Bachelor’s degree in related field

High school diploma + 8+ years sterile manufacturing

Tools

Microsoft Office

Job description

Alcami is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug product production, participate in continued process verification, and train staff across departments. The role requires leadership, data analysis, and GMP compliance to ensure robust manufacturing for commercial and clinical programs.

The position is 100% on-site with a 1st shift (Mon-Fri, 8:00am-4:30pm) and up to 5% travel.