On-Site Aseptic Manufacturing Specialist - 1st Shift

Alcami; Morrisville (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Alcami is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug production and continued process verification. You will collaborate with Formulation Development, Manufacturing, QA, Regulatory, EHS and Engineering to ensure robust production and timely investigations.

The role requires leadership, training others, and on-site execution of manufacturing activities in a regulatory environment. 1st shift, with standard hours, on-site at Morrisville, NC.

Qualifications

• Bachelor’s degree preferred with 2+ years related experience in sterile injectable manufacturing.
• 8+ years related experience with high school or equivalent certification in sterile injectable manufacturing.
• At least 1 year of experience in technical writing (deviations, SOPs, batch records, etc.).
• 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.

Skills

Leadership

Data analysis

Communication

Technical writing

Education

Bachelor’s degree in related field

High school diploma with 8+ years experience

Tools

Microsoft Office

Job description

Alcami is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug production and continued process verification. You will collaborate with Formulation Development, Manufacturing, QA, Regulatory, EHS and Engineering to ensure robust production and timely investigations.

The role requires leadership, training others, and on-site execution of manufacturing activities in a regulatory environment. 1st shift, with standard hours, on-site at Morrisville, NC.