Aseptic Manufacturing Lead - On-Site, 1st Shift

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

Job summary

Alcami Corporation is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug product manufacturing and continued process verification. You will lead investigations, author change controls, and train staff across formulation development, QA, and manufacturing in a compliant environment.

The role focuses on on-site execution, data-driven process optimization, and collaboration with cross-functional teams to ensure robust production for clinical and commercial programs.

Qualifications

• Bachelor’s degree preferred; 2+ years of related experience in sterile injectable manufacturing.
• High school diploma or equivalent with 8+ years related experience in sterile injectable manufacturing.
• At least 1 year of experience in technical writing (deviations, SOPs, batch records).
• Demonstrated leadership and training experience.

Responsibilities

• Perform data analysis, including tracking and trending of manufacturing processes to identify areas of improvement.
• Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.
• Author Change Controls to support investigations, process changes and equipment modifications.
• Author investigations and facilitate the closure of investigations on time.
• Review and approve new batch records as well as perform review of executed batch records.
• Provide training to manufacturing staff on operating procedures, batch records and GMP process rationale.
• Provide technical on-the-floor support of commercial, clinical, and validated processes.
• Support clients/stakeholders as a subject matter expert of commercial, clinical, and generic products.
• Evaluate product impact of process excursions outside proven acceptable ranges.
• Seek opportunities to improve process performance within defined ranges.
• Troubleshoot unexpected events during cGMP manufacturing and document deviations and CAPAs.
• Comply with FDA, EPA, OSHA, DEA regulations and company policies.

Skills

Leadership

Technical writing

Training

Communication

Data analysis

Education

Bachelor’s degree (related field)

High school diploma or equivalent

Tools

Microsoft Office

Job description

Alcami Corporation is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug product manufacturing and continued process verification. You will lead investigations, author change controls, and train staff across formulation development, QA, and manufacturing in a compliant environment.

The role focuses on on-site execution, data-driven process optimization, and collaboration with cross-functional teams to ensure robust production for clinical and commercial programs.