Second-Shift GMP Packaging Lead for Sterile Injectables

INCOG BioPharma; Fishers (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid vacation days

11 observed holidays

401(k) match up to 3.5%

Health & wellness plans

Job summary

INCOG BioPharma Services seeks an experienced Packaging Supervisor to lead second shift operations in the packaging department. You will oversee bulk and automated sterile packaging, drive performance to meet production goals, and ensure cGMP compliance across documentation and processes.

You will manage Packaging Associates and Team Leads, coordinate with Quality, Manufacturing, Maintenance, and Supply Chain, and drive continuous improvement while maintaining a safe, compliant workplace at our

Qualifications

• Bachelor’s degree in a scientific, engineering, or related field preferred; equivalent experience considered.
• Minimum of 5+ years GMP pharmaceutical experience in packaging, manufacturing, or related operations.
• Minimum of 2+ years of leadership or supervisory experience in a regulated environment.
• Experience with sterile drug product packaging and/or injectable devices strongly preferred.
• Ability to work overnight/second shift hours and provide leadership support during off-hours operations.

Responsibilities

• Supervise and coordinate second shift packaging operations, including bulk and automated packaging of sterile injectable products.
• Lead, coach, and develop Packaging Associates and Team Leads to achieve production, quality, and safety objectives.
• Ensure all packaging activities are executed in compliance with cGMP regulations, SOPs, and company quality systems.
• Monitor production performance, identify issues, and implement corrective actions to meet or exceed production targets.
• Review and approve batch records, logbooks, and associated documentation for accuracy and completeness.
• Oversee line setup, changeovers, and equipment readiness to minimize downtime and maximize efficiency.
• Partner with Quality, Manufacturing, Maintenance, and Supply Chain teams to resolve operational issues and support continuous improvement initiatives.
• Escalate and support investigations related to deviations, non-conformances, and equipment failures.
• Ensure proper in-process inspections and controls are performed to maintain product quality and compliance.
• Drive continuous improvement efforts related to processes, documentation, and equipment performance.
• Maintain a safe work environment by enforcing safety procedures and promoting a culture of accountability.
• Support training initiatives, ensuring all personnel are qualified and compliant with training requirements.
• Manage shift handoff communications to ensure continuity between operations teams.
• Ensure cleanliness and sanitization of packaging areas in accordance with established procedures.

Skills

Leadership

Coaching

Documentation

Problem-solving

Cross-functional collaboration

Education

Bachelor’s degree in scientific or related field

Tools

Sterile packaging equipment

Job description

INCOG BioPharma Services seeks an experienced Packaging Supervisor to lead second shift operations in the packaging department. You will oversee bulk and automated sterile packaging, drive performance to meet production goals, and ensure cGMP compliance across documentation and processes.

You will manage Packaging Associates and Team Leads, coordinate with Quality, Manufacturing, Maintenance, and Supply Chain, and drive continuous improvement while maintaining a safe, compliant workplace at our