Night-Shift Manufacturing Supervisor – GMP Excellence

Alcami-5; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

The Manufacturing Supervisor at Alcami is accountable for results in a fast-paced GMP environment, ensuring product quality for sterile injectable drugs prepared for clinical trials and commercial distribution. This role operates under SOPs and approved Batch Records in alignment with cGMP expectations.

This 100% on-site position offers a 12-Hour Night Shift (7:00 pm - 7:00 am). You will supervise 4–12 technicians, uphold SOPs and cGMPs, and provide manufacturing updates to area management to

Qualifications

• High school diploma or GED required; Bachelor's degree preferred.
• 2+ years in a regulated (cGMP) environment with drug product manufacturing experience.
• Experience working with cGMP and batch records is required.

Responsibilities

• Follow established SOPs and cGMPs to execute protocols and procedures for manufacturing operations.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
• Oversee and perform manufacturing activities, including area sanitization, equipment preparation, dispensing, compounding, filtration, isolator aseptic filling and visual inspection.
• Clearly communicate with manufacturing and cross-functional teams, including technicians and management.
• Directly supervise manufacturing team of 4-12 direct reports and drive overall performance of the manufacturing shift, including training and development, coaching/mentoring, engagement, retention and performance management.
• Maintain personnel timekeeping and time-off requests to ensure uninterrupted operations.
• Collaborate with cross-functional teams to address quality issues and implement process improvements.
• Support manufacturing department duties, including release of clinical and commercial batches, investigations, and CAPAs.
• Assist in hiring process of manufacturing technicians and other site employees.
• Other duties as assigned.

Skills

Attention to detail

Communication

Leadership

Independent work

Adaptability

Education

High School Diploma or GED

Bachelor's degree preferred

Tools

Light inspection booths

Light meters

TAPPI charts

Autoclaves

pH meters

Mixers

Stir plates

Single-use pathway parts

Aseptic connectors

Filtration assemblies

Isolators

Job description

The Manufacturing Supervisor at Alcami is accountable for results in a fast-paced GMP environment, ensuring product quality for sterile injectable drugs prepared for clinical trials and commercial distribution. This role operates under SOPs and approved Batch Records in alignment with cGMP expectations.

This 100% on-site position offers a 12-Hour Night Shift (7:00 pm - 7:00 am). You will supervise 4–12 technicians, uphold SOPs and cGMPs, and provide manufacturing updates to area management to